COVID-19 vaccines : The Court of Justice of the EU rules – Mandatory prescription required and freedom of doctors

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, opposing Giovanni Frajese, an Italian doctor, to the European Commission. This ruling, which comes in the context of the marketing authorizations (MA) of the Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech) vaccines, raises crucial questions about the obligations of doctors, the need for a medical prescription for these vaccines and their freedom to prescribe or advise against them. As the COVID-19 pandemic has marked a turning point in the management of European public health, this decision provides valuable legal clarifications, while revealing the limits of individual actions against EU regulatory acts. This article reviews the context of the case, analyses the key points of the judgment and explores its consequences, particularly for doctors.

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

The Court of Justice of the European Union (CJEU) has confirmed the inadmissibility of the appeal of Giovanni Frajese, an Italian doctor, against the marketing authorisations (MA) of 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 challenge the MAs because they did not impose any obligations on him and did not directly change his legal position.
2. Independence of judges: his argument on a possible bias of the General Court was rejected for lack of evidence.
3. Mandatory medical prescription: the Court recalls that these vaccines require a medical prescription.
4. Physicians' freedom: There is no obligation for physicians 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

• Mandatory prescription required: doctors remain the guarantors of the administration of vaccines.
• Freedom of choice: no doctor is forced to prescribe these vaccines.
• Medical liability: it depends only on the acts of prescription or administration, and not on the MAs themselves.

Outstanding and critical questions

The case raises doubts about the access to information of regulatory agencies and parliamentarians regarding vaccine contracts. Censored documents would have prevented a full evaluation of side effects and contractual clauses that would be advantageous to manufacturers.

• Lack of transparency: vaccine contracts have been partially redacted, preventing real democratic oversight.
• Failure of the chain of trust: neither parliamentarians nor health agencies would have had access to all the essential data to be able to claim to have made an informed decision in the interest of citizens.
• Growing mistrust: 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. are reportedly considering withdrawing marketing authorizations from COVID-19 vaccines because of their many side effects.

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

(editor's note: summary added at the suggestion of a reader assisted by collective intelligence and AI)

Background to the case: a doctor faced with vaccine marketing authorizations

Giovanni Frajese, a doctor living in Rome, brought an action for annulment before the General Court of the European Union in December 2022, concerning two decisions of the European Commission dated October 2022. Those decisions, C(2022) 7163 and C(2022) 7342, granted definitive MAs to the vaccines Spikevax and Comirnaty, replacing the conditional authorizations issued in 2020 and 2021 under an accelerated procedure related to the urgency of the pandemic. These marketing authorizations, granted pursuant to Regulation (EC) No 726/2004, allow the pharmaceutical companies Moderna and BioNTech to market their vaccines in all Member States of the European Union (EU).

Frajese, as a physician, felt that these decisions directly affected his professional practice. It argued that the marketing of these vaccines created an obligation for vaccinating doctors to assess their safety and efficacy, exposing them to potential liability in the event of adverse effects in their patients. He therefore sought the annulment of these decisions, arguing that they infringed his rights and his legal position.

The General Court of the EU dismissed his appeal in July 2023, deeming it inadmissible lacking interest in bringing proceedings and lack of standing to act. Frajese then appealed to the CJEU, invoking several grounds of appeal, including infringement of the rules on judicial independence, procedural errors, failure to state reasons and infringement of its right to effective judicial protection. The Court examined these complaints and delivered its judgment on 30 January 2025, confirming the decision of the General Court.

Key points of the judgment

1. Inadmissibility of the action: lack of interest and standing to bring proceedings 
   The CJEU confirmed that Vianni Frajese had neither the interest nor the standing to challenge the Commission's decisions. According to the fourth paragraph of Article 263 of the Treaty on the Functioning of the European Union (TFEU), a natural or legal person may challenge an EU act which is not addressed to him only if that act is of direct and individual concern to him or, in the case of a regulatory act, if it is of direct concern to him without requiring national implementing measures.
   • Interest in bringing proceedings: The Court ruled that the cancellation of the MAs would not confer any legal advantage on Frajese. The contested decisions are addressed exclusively to Moderna and BioNTech and do not impose any obligation on doctors to prescribe or administer those vaccines. Any possible liability of Frajese to its patients would depend on individual choices in its practice, and not on the MAs themselves.
   • Locus standi : Frajese is not directly affected, as the decisions do not change its legal position automatically or immediately. In addition, he is not individually concerned, as his status as a vaccinating doctor does not sufficiently distinguish him from any other health professional.
2. Independence of judges: a debate swept aside by the Frajese Court 
   tried to question the impartiality of the Court, arguing that the Judge-Rapporteur, having worked at the Commission for more than 20 years before 2019, could be biased. The CJEU rejected this plea, considering that no concrete evidence of bias had been provided and that Frajese had not followed the challenge procedure provided for in the Statute of the Court.
3. A notable point of the judgment concerns the annexes to the contested decisions, which stipulate that the administration of the Spikevax and Comirnaty vaccines requires a medical prescription. This means that, unlike some over-the-counter medications, these vaccines cannot be administered without the intervention of a licensed physician. This requirement, recalled by the Court, anchors their use in the context of a doctor-patient relationship, in which the health professional retains a central role.

4. Freedom of doctors: no obligation to prescribe 
   The CJEU has clearly established that MAs do not impose any obligation on doctors to prescribe or administer these vaccines. The General Court, whose findings are validated by the Court, stressed that if a doctor like Frajese doubts the safety or effectiveness of vaccines, he remains free not to recommend or administer them. This freedom is all the more affirmed because the responsibility for assessing the safety and efficacy of vaccines lies with the European Medicines Agency (EMA), and not with individual doctors. This is a crucial point insofar as we can ask ourselves whether the health agencies and the politicians who made the decisions had all the information available. It seems that the contracts were neither requested nor if they were, they were shown redacted thus preventing regulators and politicians from doing their job. How can we justify such a decision without having all the information? On this point, Frédéric Baldan and the 1000 other plaintiffs who have filed criminal complaints against Ursula von der Leyen, Pfizer and Albert Bourla are more than clear:

   “We have the contracts and what's in them makes me say 
   it 's worse than we thought.”
    

5. Effective judicial protection
   Frajese argued that the dismissal of his action deprived him of effective judicial protection, in breach of Article 47 of the Charter of Fundamental Rights of the EU. The Court refuted this argument, recalling that citizens can challenge national measures related to EU acts before national courts, which can then refer the matter to the CJEU for a preliminary ruling (Article 267 TFEU). Thus, the EU court system offers an alternative, even if it depends on the discretion of national judges.

Consequences for doctors: prescription, freedom and responsibility

The CJEU's ruling has direct implications for European doctors, particularly on three aspects: the need for a prescription, their freedom of choice and their potential liability.

• Was there a need for a prescription for COVID-19 vaccines? 
  Yes, the judgment confirms that the Spikevax and Comirnaty vaccines require a medical prescription, as stipulated in the annexes to the Commission decisions. This requirement, which stems from the European regulatory framework, distinguishes these vaccines from health products available without a prescription. It reflects their status as drugs subject to strict monitoring, particularly in the post-pandemic context, where their use has been massive. For doctors, this means that they are gatekeepers of access to these vaccines, a role that strengthens their professional authority, but also their responsibility in assessing patients' individual needs.
• Could doctors refuse to prescribe or administer these vaccines? Absolutely. The ruling emphasizes that MAs do not entail any obligation for physicians to prescribe or administer vaccines. This freedom is crucial: a doctor can, in conscience and on the basis of his or her expertise, choose not to recommend Spikevax or Comirnaty to a patient, for example, in case of doubts about their relevance or specific contraindications. The Court specifies that this decision does not engage their legal liability solely because of the MAs, because the MAs do not impose anything directly on them. Thus, physicians retain significant leeway in their practice, aligned with their ethical duty to protect the health of their patients.
• Impact on physicians' liability 
  The ruling clarifies that a physician's potential liability does not arise from MA decisions, but from the specific circumstances related to the treatment of each patient. For example, if an adverse reaction occurs after the administration of a vaccine, the responsibility of Frajese or another doctor would depend on his own act of prescribing or administration, and not on the mere existence of the vaccines on the market. The Court insists that the EMA, and not individual doctors, is responsible for verifying the safety and efficacy of vaccines before they are authorised. This relieves practitioners of an obligation to independently evaluate the overall scientific data, their role being limited to clinical application in the context of their relationship with the patient.

Broader Reflections: Balancing Public Health and Individual Rights

This judgment highlights a delicate balance between the centralized regulation of public health at the European level and the freedom of health professionals. On the one hand, the centralized MA procedure ensures harmonization of safety standards and access to vaccines in the EU, a key issue during the COVID-19 crisis. On the other hand, the recognition of the freedom of doctors not to prescribe these vaccines preserves their professional autonomy and their right to judge on a case-by-case basis, in accordance with medical ethical principles.

For doctors like Frajese, this decision may seem frustrating, as it limits their ability to directly challenge EU acts. However, it reaffirms that their power to act lies in their day-to-day practice and in appeals at national level, where they can invoke potential irregularities in European acts via local courts.

The CJEU's judgment of 30 January 2025 in the case of Frajese v. Commission closes a legal chapter related to COVID-19 vaccines, while opening up perspectives on the role of doctors in an integrated European health system. Yes, a prescription was required to administer Spikevax and Comirnaty, anchoring doctors at the heart of the process. Yes, they could refuse to prescribe them, their professional freedom being preserved. This decision, although technical, is a reminder that medicine remains a human practice, where science, regulations, and ethics meet in each consultation. For European doctors, it offers a welcome clarification: their responsibility is individual, not dictated by Brussels.

However, there are still two doubts about the information contained in the vaccine contracts:

• Has the EMA, in its capacity as regulator, obtained all the necessary information on vaccines, including key elements on contracts and vaccine purchase orders? There is reason to doubt since to date none of the regulatory agencies seem to have obtained an unredacted version of the vaccines. When the non-profit BonSens.org referred the matter to the French administrative court against Santé Publique France in 2021 in order to obtain the contracts, redacted versions were presented! When the Council of State was seized of the appeal of the decision of the Administrative Court, a point that the association had argued by its lawyer to the Council was that in France, a contract should be signed in French. SPF should therefore have had a French translation of these contracts. No answer!
• This doubt also extends to parliamentarians who voted for vaccination obligations for certain groups of people and the health pass without having been fully informed. On July 12, 2021, President Macron announced the vaccination obligation for some and passes it based on scientific evidence. On July 14, 2021, Dr. McCullough declared “none of his assertions are founded” in a debriefing on France-Soir.  BonSens.org had warned parliamentarians in France about the consequences of a vote in favor of mandatory vaccination and the pass. “So that this time, it will no longer be possible to say: 'we didn't know',” one of the letters read.
• How can these people today legitimately declare that they have acted in the interest of citizens if they have not been able to see the contracts, one of the key elements in decision-making?

Imagine buying a house without the notary being able to guarantee the origin of the property or the waterproofing of the roof, because the expert was not able to access the attic. The notary tells you: “you are buying as it is without having been able to check the construction, but with an incomplete expertise”. As soon as it starts to rain, you notice that the house is not waterproof. There are several types of recourse against the seller, who cannot exonerate himself from all his responsibilities.

Well, in the context of the vaccine contracts, parliamentarians, on the recommendation of experts from health agencies, voted without knowing if there were any side effects. They have even often been told that they are non-existent , if we are to believe the former Minister of Health Aurélien Rousseau,"Mr. Disinformation by Example“.  In addition, the contracts signed with Pfizer, Moderna and the other manufacturers contain clauses exonerating them from all liability. “A contract so favourable to the industrialist, it seems abnormal to me,” said Olivier Frot, a doctor of law, one of the few experts to have really analysed the contracts.

In the chain of trust, parliamentarians have not verified or given themselves the means to verify the statements of local regulatory agencies, which themselves have not done their due diligence on instrumental elements to ensure people's safety. It is indeed a break in the chain of trust, and it is therefore not a surprise that the French have lost confidence in political action, especially since it is the citizen who pays.

80% believe that the government is not acting in the interest of the French people, and 76% do not trust the government. (Source: France-Soir/BonSens.org survey)

It is therefore not surprising that President Trump and his Secretary of Health Robert Kennedy Jr. are considering withdrawing authorizations for these therapies given the many side effects (these vaccines are said to have more side effects than all other vaccines combined) and the biased and captured scientific data because they are published in non-independent journals. To be continued.