COVID-19 Vaccines: The Court of Justice of the EU RULES-Mandate prescription required and freedom of doctors

< IMG LOADING = "Lazy" SRSC = "/Sites/Default/Files/Styles/Medium/Public/2025-02/COVID%20vaccine%20engish.png ? Itok = VTFYKDJ_" Width = "1280" Height = "720" Alt = "COVIVE vaccine" Class = "Lazyload Img-Fluid Image-Style-Max-1300x1300" SRC = "/Sites/Default/Files/Styles/Max_1300x1300/Public/2025-02/COVVID%20vaccine%20engish.png ? iTok = vucpv5cl"/> France-Soir, ia COVVI-19 Vaccines: The Court of Justice of the EU RULES-Mandate prescription and Freedom of Doctors < P > 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 < strong > crucial questions about the obligations of doctors , < Strong > The Need for a Medical Prescription for these vaccines and their Freedom to prescribe or Advise Against Them. As the COVVI-19 Pandemic has marked a turning point in the management of European public health, this decision provids valuable legal clarifications, while revealing the limits of individual actions againstu eu regulatory acts. This article reviews the context of the case, analyzes the key points of the judgment and explores its consequences, particular for doctors.

< p >< Strong > background to the Case: a Doctor Faced with Vaccine Marketing Authorizations

< P > Giovanni Frajese, a Doctor Living in Rome, B3 Concerning Two Decisions of the European Commission Dated October 2022. Those Decisions, C (2022) 7163 and C (2022) 7342, < Strong > GRANTED DEFINIVIVE 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, Grantd 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). < P > Frajese, as a physician, Felt that These Directly Decisions Affected His Professional Practice. It argued that the marketing of these vaccines created an obligation for vaccinating doctors to assess their safety and efficient, exhibition 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. < P >The General Court of the EU Dismoysed HIS APPAL IN JULY 2023, Deeming It Inadmissible Lacking Interest in Bringing Process and Lack of Standing to Act. Frajese then appeal to the cjeu, invoking Several Grounds of Appeal, Including Infringement of the Rules on Judicial Independence, Processive Errors, Failure to State Reasons and Infringement of its right to effective judic protection. The Court examines these complain and delivered its judgment on 30 January 2025, Confit the decision of the general court.

< p >< Strong > Key Points of the Judgment

< ol >~ 60 >< Strong > inadmissibility of the action: Lack of Interest and Standing to Bring Proceedings & nbsp; 62 > The Cjeu Confirmed that < Strong > Vianni Frajese Had Neither the Interest Nor the Standing To Challenge The Commission's Decisions. Accord 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 National Requiring Implementing Measures. < Ul >< li >< Strong > Interest in Bringing Proceedings: The Court Ruled that the cancellation of the mas would not < Strong > confer anyy 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 Liabibility of Frajese to its patients Wow Depend On Individual Choices in Its Practice, and not on the mas themselves. < li >< Strong > Locus Standa : Frajese is not < Strong > directly affected , as the decisions do not change its legal position automatically or imately. In addition, he is not individually concerned, as his status as a vaccinating door do not sufficiently distinguish him from any other health professional.

< li >< Strong > independence of Judges: a debate stept aside by the frajese short & nbsp; ~ 60 > tried to question the impartiality of the short, arguing that the judge-rapporteur, having worked at the commission for More than 20 Years Before 2019, Could Be Biased. The cjeuction this plea, considering that no concrete evidence of bias had been provided and that frajsee had not followed the challenge procedure provided for in the statute of the short.

< li > a < Strong > notable point of the judgment concerns the annexes to the challenge decisions, which stipulate that < Strong > the Administration of the Spikevax and Comirnaty Vaccines require a medical prescription . & nbsp; this means that, Unlim Some Over-the-Counter Medications, < Strong >These vaccines cannot be administered with the intervention of a license physician . This requirement, Recalled by the Court, < Strong > Anchors their use in the context of a doctor-pasta , in Which the Health Professional < Strong > Retains a central Role . < li >< P >< Strong > Freedom of Doctors: No obligation to prescribe & nbsp; < Br > The Cjeu has clearly established that mas of not impose < Strong > Any obligation on doctors to prescribe or administer these vaccines . The General Court, Whose Findings Are Validated by the Court, Stéssed that if a doctor Like Frajese Doubts the Safety or Effectiveness of Vaccines, < Strong > He remains free not to recommend or administer them. This Freedom is all the more affirmed because the responsibility for Asssing the Safety and Effectcy of Vaccines Lies with the European Medicines Agency (EMA), and not with individual doctors. This is a crucial point insofar as we can ask beselves that 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. < Strong > 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 Complains Against Ursula Leyen, Pfizer and Albert Bourla Are More Than Clear:

< P Class = "Text-Align-Center" > “~ 60 > We have the contracts and what's in them Makes Me Say & nbsp; < Br >< EM > it < Strong > 'S Worses Than We Thought . ”< br > & nbsp;

< li >< Strong > Effective Judicial Protection < Br > 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 short refute this argument, recalling that citizens can challenge national measures related to eu acts before national courts, which can do the matter to the cjeu for a prelimary ruling (article 267 tfeu). Thus, the EU Court System Offers An Alternative, Even if it depends on the discretion of National Judges. < P >< Strong > Consequences for doctors: prescription, freedom and Responsibility

< P > The Cje's Ruling has < Strong > Direct implications for European Doctors , Particularly On this aspects: < Strong >The needs for a prescription, their freedom of choice and their potential liability. < UL >< li >< Strong > was there a nEED for a prescription for covid-19 Vaccines ? & nbsp; < Br >Yes, the judgment confirms that the spikevax and coirnaty vaccines require a medical prescription, as stipulated in the annexes to the commission decisions. This requirement, which Stems from the European Regulatory Framework, distinction 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 thesese vaccines, a role that strengthens their professional authority, but also their responsibility in assessing patients' individual needs.

< li >< Strong > COULD Doctors refuse to prescribe or administer these vaccines ? Absolutely . The Ruling Emphasizes that mas < Strong > do not court 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 Cumirnaty to a Patient, for Example, in Case of Doubts About Their Livance or Specific Constestments. The Court Specifies that this Decision DOES NOT NOT SUGGAGE THEIR LEGAL LIABILITY SOLELY BECAUSE OF THE MAS, BECAUS THE MAS D NOT IMPOSE Anything Directly on them. Thus, CHESICIANS RETAINE Significing Leeway in Their Practice, Aligned with their Ethical Duty to Protect the Health of Their Patients. < li >< Strong >Impact on physicians' Liabibility & nbsp; < Br > The Ruling Clarifies that < Strong > a Physician's potential liability does not arise from my decisions , goal from < Strong > 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 weld depend on his own act of prescibing or administration, and not on the member existence of the vaccines on the market. The short insists that < Strong > the Ema , and not individual doctors, is < Strong > Responsible for Verifying the Safety and Effectcy of Vaccines Before are Authorized . This reliefs 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.

< P >< Strong > Broader reflections: Public Balancing Health and individual Rights

< P > 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 pre-serves vaccines their professional autoomy and their right to judge on a case-by-case basis, in accordance with medical ethical principles.

< P >For doctors like frajsee, this decision may seem frustrating, as it limits their ability to directly challenge eu acts. However, it reaffirms that their power to act in their day-to-day Practice and in Appeals at National Level, where they can invoke potential irregularities in European acts via local short.

< P > The Cje's Judgment of 30 January 2025 In the case of Frajesse v. Committee closed 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 Cumirnaty, anchoring doctors at the Heart of the Process. Yes, < Strong > they COULD refuse to prescribe them, their professional freedom being preserved. This decision, Although Technical, is a reminder that medicine remains in human practitioner, where science, regulations, and ethics meet in each consultation. For European Doctors, it offers A Welcome Clarification: < Strong > their responsibility is individual, not dictated by Brussels .

< P > However, there are Still Two Doubts about the Information contained in the vaccine contracts: < Ul >< li >Has the ema, in its capacity as regulator, obained all the necessary information on vaccines, include key elements on contracts and vaccine purchase orders ? there is reason to doubt since to date of the regulatory agencies seem to have obtained an unredaced version of the vaccines. When the non-Profit Bonsens.org Retrred the Matter to the French Administrative Court Against Health Public France in 2021 In order to obtain the Contracts, Redated Versions Were Predented! & Amp; Nbsp; 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 NOTREFORE HAD HAD A FRENCH Translation of these contracts. No ANSWER!

~ 60 > this double extends < Strong > to parliamentarians who vote for vaccination for certain groups of people and The Health Pass < Strong > without HAVING BEEN FULLY informed . & nbsp; 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 “< EM > None of his assertions Are Founded ” In a debriefing on France-Soir. & Amp; nbsp; & nbsp; .org had warned parliamentarians in France about the consequences of voting in favor of Mandate Vaccination and the Pass. “< em >So that this time, it will no long be possible to say: 'we didn't know' , ”One of the Letters Read. < li > How can these people today legitimately declare < Strong > that they have actd in the Interest of Citizens If they have not ben able to see the contracts, one of the key elements in Decision-Making ?< P > Imagine Buying A House Without the Notary Being 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: “< em > You are buying as it is without having been able to check the construction , goal with an incomplete expertise ”. As soon as it starts to rain, you notice that the house is not waterproof. There are Several Types of Recruit Against the Seller, Who Cannot Exonrate Himself from all his responsibility.

< P > Well, in the Context of the Vaccine Contracts, parliamentarians, on the recommendation of Experts from Health Agencies, vote < Strong > without Knowning if there were any side effects. they have even often been told < Strong > that they are not existed , if we are to Believe the form minister of Health Aurélien Rousseau, ” < EM > MR. Example “. Me, ”Said Olivier Frot, A Doctor of Law, One of the Few Experts to have really analyzed the contracts. < P >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 therefore their due diligence on instrumental elements to ensure people's safety. & Amp; nbsp; it is indeed a break The Chain of Trust, and it is there not a surprise that french have lost confidence in political action, eSpecially since it is the citizen who country.

< p > 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)

< P >It is there is surprise that prescribing that President Trump and His Secretary of Health Robert Kennedy Jr. Are Considering Withdrawing Autorizations for these therapies Given the Many Side Effects (these vaccines are Said to Have More Side Effects Than All Other Vaccines Combéd) and the biased and Scientific Data because they are published in non-indengendent journals. To be continued.

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