Trials pending at the European Court of Justice dramatically reveal the undemocratic state of the European Union
According to the EU court (the reporting judge for many years was in the highest-ranking service of the opposing litigant/EU Commission), member states can also use coercive measures to have doctors use experimental substances based on genetic engineering
EU on the way directly in an inhuman totalitarianism
Two cases pending before the European Court of Justice (C-139/24 P and C-148/24 P) concern the violation of the following fundamental values that are essential for a democratic constitutional state:
- Independence and impartiality of judges in EU courts
- EU citizens’ fundamental right to effective legal protection
- Prohibition of pharmacological experiments on humans without their informed and therefore voluntary consent
The two lawsuits have their origins in two actions for annulment (Art. 263 (4) TFEU) brought by an Italian father of minors against the unconditional five-year marketing authorization granted by implementing decisions of the EU Commission for the two so- called mRNA Covid-19 “vaccines” Comirnaty from Pfizer/BioNTech (T-109/23) and Spikevax from Moderna (T-108/23).1
https://drive.google.com/file/d/1cEh5keOr89SfE4f1T-guRmw-nsV9Kvvi/view?usp=drivesdk
1 By way of example, reference is made to the documents in the proceedings concerning the action for annulment against the marketing authorisation for Comirnaty of Pfizer/BioNTech.
Due to the “vaccination” propaganda rolled out by the EU Commission and the Italian government and gross deception about the effective nature, efficacy and risk profile of these two substances, which are also approved for use on children, the mother of the two children had obtained authorization in court in Italy to have the children injected with these experimental substances based on genetic engineering, even against the will of the father.
Despite the father’s desperate objection, the courts seized at first instance granted the mother’s application in blind faith in the official presentation of the nature, efficacy and alleged safety of these experimental substances. The Italian courts did not grant the father’s request to refer the question of the legality of the then still conditional marketing authorization of these two substances to the European Court of Justice for a preliminary ruling (Art. 267 TFEU).
The father therefore brought two actions for annulment (Art. 263 (4) TFEU) before the General Court of the European Union in 2023 against the now unconditional market authorization of these two substances.
The results of the first instance proceedings reveal the undemocratic state of the European Union, including in its judicial body, and are of dramatic significance for all EU citizens, which must not be withheld from the public.
Appeals have already been lodged against the decisions of the General Court of the EU.
https://drive.google.com/file/d/1uvBPD5-QyLFLRr_gRb-jjtc85Tyrjpca/view
1. Highly problematic composition of the courts of the European Union
The independence and impartiality of judges are basic prerequisites for a fair trial (art. 6 European Convention on Human Rights, art. 47 Charter of Fundamental Rights of the EU).
However, this basic requirement for a fair trial is absurdly not guaranteed in the courts of the EU!
The two lawsuits now pending before the European Court of Justice (the opposing party is the European Commission) concern, among other things, the illegality of the amendment to the definition of gene therapy medicinal products introduced by Commission Directive 2009/120/EC. As a result, substances that are simply formally declared as “vaccines against infectious diseases,” irrespective of the ingredients and their mode of action, were excluded from the application of the much stricter regulation for the approval of gene therapy medicinal products.
This directive was issued in 2009 by the EU Commission under the presidency of José Manuel Barroso.
In the proceedings at first instance, the reporting judge was Dr. Johannes Christoph Laitenberger, who was a high-ranking political employee of the European Commission in various functions for many years until his move to the position of judge at the General Court of the EU in 2019
https://curia.europa.eu/jcms/jcms/Jo2_7035/en/
From 2004 to 2005, the judge reporting in the trials was a member of the cabinet of Commission President José Manuel Barroso. From 2005 to 2009, he was Spokesman and Head of the Spokesman’s Service of the Commission. From 2009 to 2014, he was Head of Cabinet in the Cabinet of Commission President José Manuel Barroso.
The EU Commission with President Barroso has issued Directive 2009/120/EU.
In 2014, Laitenberger was appointed Deputy Director-General of the Commission’s Legal Service before heading the Commission’s Directorate-General for Competition from 2015 to 2019.
According to the basic principle recognized internationally in democratic legal systems, both the court and the individual judge must be objectively impartial, i.e. offer sufficient guarantees if there are doubts about objectivity for a reasonable person. Even appearances are important.
The court of first instance of the EU found that, despite the objection to the obvious lack of the necessary independence and impartiality of the judge reporting in the two court proceedings, as provided for in Art. 47 of the Charter of Fundamental Rights of the EU, the judge was not to be replaced.
However, this decision does not correspond to the average citizen’s and many lawyers’ sense of justice.
2. Fundamental right to effective legal protection denied to EU citizens
The areas in which the EU has legislative powers are constantly being expanded, while EU citizens are usually not granted effective legal protection against the actions of the EU institutions that directly affect them, due to a jurisdiction that unlawfully restricts their right to sue.
The situation has been becoming increasingly intolerable for decades. Over 20 years ago, the then Advocate General of the European Court of Justice, Sir Francis Geoffrey Jacobs, explained in his Opinion in Case C-50/00 P (see paragraphs 37 to 75 and paragraphs 100 and 101) how the restrictive case law, which violates article 263 TFEU and article 47 of the Charter of Fundamental Rights of the EU, denies EU citizens effective legal protection specifically against acts of the EU institutions which adversely affect a large number of individuals and thereby cause widespread damage.
https://curia.europa.eu/juris/showPdf.jsf;jsessionid=2FD981120FFD45BB98649F2D76EEE DCB?text=&docid=47224&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&c id=3752034
The actions for annulment filed by the Italian father at the General Court of the EU against the unconditional 5-year (renewable) market authorization of the two so- called Covid-19 mRNA “vaccines” (Comirnaty from Pfizer/BioNTech and Spikevax from Moderna) concern unlawful acts of the EU Commission that affect all EU citizens (approx. 448 million people) and their future generations. The already known damage caused by these unlawful acts is enormous. And the potential damage is almost incomprehensible!
Due to the justified criticism of many EU legal experts, art. 263 para. 4 TFEU was amended so that every EU citizen can bring an action against legal acts of a regulatory nature that directly affect them and do not entail implementing measures.
Art. 263 (4) TFEU now reads as follows:
Any natural or legal person may, under the conditions laid down in paragraphs 1 and 2, institute proceedings against acts addressed to that person or which are of direct and individual concern to him or her, or against regulatory acts which are of direct concern to him or her and which do not entail implementing measures.
The implementing decisions of the EU Commission challenged in the two actions for annulment are indisputably of a regulatory nature, as they consist, inter alia, of annexes which are essentially of general application and in some cases are even addressed directly to healthcare professionals and users (health authorities etc.) as well as potential vaccinees.
https://ec.europa.eu/health/documents/community- register/2022/20221010157165/anx_157165_en.pdf
The summary of product characteristics (SmPC, article 11 Directive 2001/83/EC) and the package leaflet (article 59 Directive 2001/83/EC) form an integral part of the marketing authorization for medicinal products
The SmPC is the basis for enabling/guaranteeing healthcare professionals (and thus patients/vaccinees) to use the medicinal product safely and effectively.
The package leaflet provides comprehensive information on the safe and appropriate use of the medicinal product. It is primarily intended for patients/vaccinees.
Despite this obvious factual and legal situation, the EU court of first instance came to the conclusion that the contested implementing decisions of the EU Commission, with which the two so-called Covid-19 “vaccines” were approved, were only directed at the respective manufacturer (BioNTech and Moderna).
In its attempt to deny the father standing, the court even went so far as to claim (see para. 56 of the court order) that the EU Commission’s implementing decisions did not classify the substance in question (Comirnaty from Pfizer/BioNTech and Spikevax from Moderna) pharmacologically, but merely granted an authorization for these substances.
https://drive.google.com/file/d/1jIHkTCuNUAaT20IaHyIK_e_cnUO4KPVj/view
However, this corresponds to a misunderstanding of the most rudimentary principles of pharmaceutical law, because it is precisely the authorization decision that legally determines the pharmaceutical-therapeutic class (category) of the medicinal product for all and declares the medicinal product as belonging to this pharmaceutical- therapeutic class (in this specific case “vaccine” versus “advanced therapy medicinal product”) (see article 59 Directive 2001/83/EC)!
When the court writes “Insofar as Annex I of the implementing decision states in particular that this medicinal product is an mRNA vaccine whose therapeutic indication is active immunisation in persons aged six years and over for the prevention of Covid-19 caused by SARS-CoV-2, it must be assumed that this information is included in the summary of product characteristics and thus substantiates the authorisation granted” this is an expression of the fact that the European Commission’s implementing decision is obviously being denied its effective content and meaning “by hook or by crook.”
This is because a marketing authorization is not “concretized,” but is granted or not granted for a medicinal product with the pharmaceutical-therapeutic properties declared in the marketing authorization (“vaccine” versus “advanced therapy medicinal product – gene therapy”).
And the characteristics of the medicinal product declared in the marketing authorization have general validity, because they apply not only to the pharmaceutical company submitting the application, but also to the Member States, all authorities, healthcare professionals and vaccinees.
Article 59 of Directive 2001/83/EC stipulates that the package leaflet must be drawn up in accordance with the summary of product characteristics. Among other things, it must contain the pharmaceutical-therapeutic class or mode of action in a form easily understood by the patient in order to identify the medicinal product.
In the package leaflet, Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) are referred to as Covid-19 mRNA vaccines, contrary to their actual mode of action and composition.
Both the information for healthcare professionals and the package leaflet are completely misleading in the case of Comirnaty and Spikevax!
The implementing decisions of the EU Commission have an abstract-general effect, as they have been used to bring dangerous experimental substances based on genetic engineering, which correspond in their mode of action to a gene therapeutic agent, onto the market as a “vaccine” for use on the entire population, right down to the smallest children, in the Covid-19 “vaccination campaign” pushed by the Commission with the predicate “safe,” bypassing all safety precautions and conditions.
Apart from the fact that not even the clinical studies initially required for the conditional approval of the two substances were carried out for the purpose of confirming efficacy and safety, neither genotoxicity studies, nor carcinogenicity studies, nor mutagenicity studies (i.e. studies on the risk of DNA modification) were carried out.
This has an abstract-general effect on the entire EU population, as it has brought highly dangerous experimental substances based on genetic engineering onto the EU market for mass use through so-called “vaccination campaigns.”
The main difference between the approval procedure for a genetically engineered medicinal product and that for conventional vaccines is that the risk factors to be considered for genetically engineered products include the degree of integration of nucleic acid sequences or genes into the human genome, long-term functionality and the risk of oncogenicity.
3.) Violation of the prohibition of pharmacological experiments on the human being without its free and informed consent – frighteningly totalitarian attitude of the General Court in complete contradiction to the principles of EU law
Due to its fundamental importance, the protection of the human genome is anchored at supranational and international level. See the Convention on Human Rights and Biomedicine of the Council of Europe of 1997, as well as the Universal Declaration on the Human Genome and Human Rights of the 29th UNESCO General Conference in November 1997.
The fundamental right of people to not be subjected to pharmacological experiments without their free and informed consent is enshrined at EU and international level (EU Regulation No. 536/2014, Nuremberg Code).
By categorizing these substances as “vaccines,” which does not correspond to the actual mode of action of Comirnaty and Spikevax, the population of the EU is being grossly deceived and therefore cannot freely consent to the injection of these substances!
The EU population, which has been grossly deceived, has been and will be de facto subjected to a criminal pharmacological mass experiment and degraded to laboratory animals by the contested implementing decisions.
This abstract-general effect does not require an implementing act, but results directly and immediately from the implementing decision.
The implementing decision radically violates Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use and the Nuremberg Code.
The pretense of false facts in the contested implementing decisions led and leads automatically to mass involuntary treatment with an experimental substance.
The contested implementing decisions of the European Commission also have an abstract- general and immediate effect with criminal relevance because, despite the fact that the clinical studies initially required to confirm the propagated efficacy and safety (and thus the propagated positive benefit/risk ratio of Comirnaty) were never carried out, they were nevertheless granted unconditional marketing authorization for five years (renewable), and the Commission declared in a bare lie that the conditions for unconditional marketing authorization had been met.
https://ec.europa.eu/health/documents/community- register/2022/20221010157165/dec_157165_en.pdf
The placebo groups were dissolved a few months after the start of the “vaccination campaign” on the cynical pretext that, for ethical reasons, the participants in the control group could not be exposed to any risk of Covid-19 disease.
https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Vaccine-trial-design- 2021.1
With the contested implementing decisions, the EU Commission has approved Comirnaty and Spikevax for mass use on the EU population for five years and renewable, without conditions, in the most brutal violation of fundamental principles of EU pharmaceutical law, although the efficacy and safety of these substances have never been confirmed in clinical trials.
It could hardly be more cynical and criminal, because it deceives and potentially harms around 448 million EU citizens!
Finally, the court itself even presents the reason why both the plaintiff and his children, as well as every EU citizen, are directly affected by the two implementing decisions of the EU Commission in its reasoning.
In paragraph 47 of its decision, the court displays an absolutely unacceptable and frighteningly totalitarian attitude.
The court claims that the authorities of the Member States have full discretion to decide whether it is appropriate to impose the use of Comirnaty or Spikevax on doctors, if necessary by means of coercive measures!
This contradicts the most fundamental principles of EU law and the European Convention on Human Rights. Imposing coercive measures on doctors to use a substance that is demonstrably experimental and based on gene therapy is in line with the mindset of totalitarian regimes, but not with the EU treaties, the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights!
This one paragraph in the reasoning of the court has – as an obiter dictum – a highly dangerous effect and must not be allowed to stand! For if it were to stand, this would be tantamount to an obvious departure of EU jurisdiction from all fundamental principles of EU law!
Since, according to the court, it would be at the discretion of the Member States to use the experimental substances Comirnaty and Spikevax, which are based on genetic engineering and whose efficacy and safety have never been confirmed in clinical studies, “even with coercive measures,” the plaintiff and his children, as well as all EU citizens, have an unmistakable personal existing and present interest in the immediate revocation of the authorization of Comirnaty and Spikevax as “vaccines.”
Following the frighteningly authoritarian logic of the court, there is hardly a more direct concern than that of the Italian plaintiff, his children, indeed all EU citizens, who see themselves at the mercy of the authority of their member states, which, according to the legally erroneous opinion of the EU court, can also forcibly apply experimental genetic engineering substances, such as Comirnaty and Spikevax, to the citizens!
If the European Commission had not treated and approved Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) as a conventional vaccine, but treated and declared them as what they are, namely experimental substances based on genetic engineering:
- their (even conditional) approval for use in the context of “vaccination campaigns” for the entire population would never have been possible,
- the mother of the plaintiff’s minor children would probably never have had the idea of obtaining court authorization to subject their two minor children to this injection, even against the father’s desperate objection,
- the competent courts of the Member State Italy would never have given authorization for the genetic engineering and experimental treatment of healthy children, and
- the entire EU population would probably not have been prepared to have this substance injected, even repeatedly, into themselves (and their children!).
The European Court of Justice must now rule on the admissibility of the Italian father’s actions for annulment.
Rarely has a decision of the European Court of Justice on the admissibility of nullity actions brought by individual plaintiffs had such far-reaching fundamental significance.
Therefore this raises the question: EU, quo vadis?
C-139 24 P European Court of Justice Appeal
DDr. Renate Holzeisen, Attorney-at-law
Italy – Bozen (South Tyrol) – Bahnhofallee 7 – holzeisen@holzeisen-legal.com
Member of the South Tyrolean Parliament and the Regional Council of Trentino-Alto Adige