On 30 January 2025, the European Court of Justice (ECJ) delivered a pivotal judgement in case C-586/23 P, involving Italian physician Giovanni Frajese and the European Commission. This ruling has significant implications for medical practitioners administering COVID-19 vaccines, particularly concerning the necessity of medical prescriptions and doctors' autonomy in their professional practice.
Background of the Case
In October 2022, the European Commission granted definitive marketing authorisations (MAs) for the COVID-19 vaccines Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech), transitioning from the conditional approvals issued during the pandemic's peak. Dr. Frajese contested these decisions, arguing that the widespread availability of these vaccines imposed an obligation on physicians to assess their safety and efficacy, thereby exposing them to potential liability for adverse patient outcomes. He sought annulment of the MAs, claiming they infringed upon his professional rights and legal standing.
The General Court of the EU dismissed his appeal in July 2023, citing a lack of direct concern and standing. Subsequently, Dr. Frajese appealed to the ECJ, raising issues related to judicial independence, procedural errors, inadequate reasoning, and the right to adequate judicial protection. The ECJ examined these claims and, on 30 January 2025, upheld the General Court's decision.
Key Findings of the Judgement
1. Inadmissibility of the Action: Lack of Interest and Standing
The ECJ confirmed that Dr. Frajese lacked the interest and legal standing to challenge the Commission's decisions. According to Article 263 of the Treaty on the Functioning of the European Union (TFEU), individuals may contest an EU act not addressed to them only if it directly and individually concerns them or, in the case of a regulatory act, if it directly affects them without necessitating national implementing measures. The Court determined that the MAs did not obligate physicians to prescribe or administer these vaccines. Any potential liability from adverse effects would result from individual medical decisions, not the MAs themselves.
2. Independence of Judges
Dr. Frajese questioned the impartiality of the Court, alleging potential bias due to the Judge-Rapporteur's prior employment with the European Commission. The ECJ dismissed this claim, noting the absence of concrete evidence of bias and highlighting that the proper procedures for challenging judicial impartiality had not been followed.
3. Mandatory Medical Prescription for COVID-19 Vaccines
A notable aspect of the judgement is the reaffirmation that the administration of Spikevax and Comirnaty vaccines requires a medical prescription. This stipulation ensures that these vaccines cannot be administered without the involvement of a licensed physician, thereby reinforcing the central role of healthcare professionals in the vaccination process.
4. Freedom of Doctors: No Obligation to Prescribe
The ECJ clarified that marketing authorisations do not compel physicians to prescribe or administer these vaccines. Doctors can recommend or withhold vaccination based on their professional judgement. The responsibility for assessing the safety and efficacy of vaccines lies with the European Medicines Agency (EMA), not with individual doctors. This delineation ensures that physicians are not held accountable for the inherent properties of the vaccines but are responsible for their clinical decisions regarding individual patients.
Legal Implications for Physicians
This ruling has several critical implications for medical practitioners:
- Reinforced Autonomy: Physicians maintain the authority to make independent clinical decisions about prescribing COVID-19 vaccines, based on their assessment of each patient's circumstances.
- Clarified Liability: Doctors are not liable for the general safety or efficacy of the vaccines as determined by the EMA. Their legal responsibility pertains to their specific actions in prescribing or administering the vaccines.
- Mandatory Prescription Requirement: The necessity of a medical prescription for these vaccines underscores the importance of a thorough doctor-patient consultation, ensuring informed consent and personalised medical advice.
Conclusion
The ECJ's decision underscores the pivotal role of medical professionals in administering COVID-19 vaccines, affirming their autonomy and clarifying the boundaries of their legal responsibilities. By mandating prescriptions for these vaccines, the Court reinforces the necessity of personalised medical assessments, thereby safeguarding both patient welfare and the professional integrity of physicians.
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