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Robert W Malone MD: Criminal Complaint vs. SwissMedic/mRNA Vax

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Criminal Complaint vs. SwissMedic/mRNA Vax

Swiss Lawyer Philipp Kruse provides a comprehensive summary of mRNA “vaccine” regulatory failures and lies

ROBERT W MALONE MD, MS   Apr 02, 2024

 

On July 14, 2022, Philipp Kruse filed a carefully worded comprehensive legal complaint against the Swiss Regulatory authority known as Swissmedic for their role in enabling deployment of the COVID mRNA “vaccines” into the population of Switzerland. On 28 March 2024, the complaint was refiled with substantial updates and amendments. This complaint provides a comprehensive summary of the case against the official regulatory positions and activities promoted by Swissmedic, which closely parallel those taken by the US FDA, Health Canada, the European Medicines Agency and most other national regulatory authorities.

Swissmedic is the Swiss Agency for Therapeutic Products. More precisely, Swissmedic is the Swiss surveillance authority for medicines and medical devices, and is registered in Bern, Switzerland. Swissmedic fulfills a Swiss federal mission similar to the US HHS Food and Drug Agency (FDA).

Key complaints detailed in this filing include the following criminal acts, which appear to apply equally to many other national regulatory authorities:

Criminal acts performed by Swissmedic

  1. Initial authorization that breaches the law and duties

  2. Perpetuation of illegal authorizations that breach the law and duties

    1. Disregard for all additional indications of risk

    2. Absence of a “life-threatening or debilitating” disease

    3. No benefits from ineffective to harmful mRNA injections

    4. Omission of the most elementary safety and effectiveness tests

    5. Swissmedic blocked effective alternative treatments

    6. Benefit-risk analysis – Clearly a negative profile

    7. Continuing despite an obviously negative benefit-risk ratio

  3. No product monitoring proportionate to the risks

  4. Misleading information not proportionate to the risks

  5. Medical malpractice – lack of information, lack of reports

  6. Swissmedic out of control and acting to the detriment of the state and the

    population

As summarized in his “X” bio (see image above and his academic CV which can be viewed here), Mr. Kruse is an experienced Swiss and International Law specialist. Having filed this legal complaint, he posted a PDF copy on “X” for download and review, promptly resulting in “X” designating his account “Temporarily Restricted” due to “unusual activity”.

UPDATE: Due to the censorship of the prior account, Philipp Kruse has now established a new “X” account at @KruseLawyer

I first met Mr. Kruse while visiting Stockholm to lecture on the COVIDcrisis and fifth generation warfare, and he told me of the legal case he was about to file in Switzerland regarding the governmental mismanagement of the response to COVID. Impressed with his knowledge of international law, I invited him to speak at the most recent Senator Johnson hearing in the US Senate regarding his understanding of the legal underpinnings of the proposed WHO pandemic treaty and International Health Regulation modifications. Below is a video of his brief testimony. As you can sense from the video, Mr. Kruse is a very meticulous, detail-oriented and fundamentally conservative (in the classical sense- cautious and non-flamboyant in demeanor and actions) Swiss attorney. He is committed to respect for human rights, but is certainly not a wild-eyed far-right radical. His positions are carefully researched and documented.

Mr. Kruse and his colleagues have addressed their reasons for taking these actions in a press release dated 24 March 2024.

I suggest that the legal complaint which Mr. Kruse has compiled and submitted to Swiss legal authorities is the most comprehensive summary of the regulatory mismanagement and fraud which has taken place at virtually all western national regulatory authorities during the push for mandatory deployment and uptake of the COVID mRNA “vaccines”, and can serve as a template for both other complaints as well as expert witness testimony. Furthermore, I am struck by the parallels between the actions of the Swiss national regulatory authority, the US FDA/CDC, and virtually all other western national regulatory authorities. This strongly suggests close communication and/or collusion among these agencies and their political and bureaucratic State managers during the COVIDcrisis.

With that in mind, I have included key sections from the executive summary of the complaint below. A PDF copy of the full executive summary can be found here (independent archive) and here, and the press release together with both the summary and the full 450 page complaint document can be found here.


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Swissmedic criminal claim – “Executive Summary” (2.0)

(redacted for general legibility)

“All things are poison, and nothing is without poison; it is but the dosage that

makes a thing not poison.”

(Paracelsus [1493-1541], Swiss physician, alchemist and philosopher)

 

“Any person handling therapeutic products must take all measures necessary according to the state of the art to ensure that human or animal health is not endangered.”

(Art. 3, Federal Act on Medicinal Products and Medical Devices, Therapeutic

Products Act, TPA).

Suspicion

In the present case, we are dealing with the greatest danger to and violation of human health caused by medicinal products themselves and by misinformation from public officials in this regard that has ever occurred in the history of Switzerland. The mRNA “vaccines” against SARS-CoV-2 infections, which are largely ineffective and pose an above-average risk to human health, have been proven to pose a far greater threat to the healthy population than the SARS-CoV-2 pathogen itself, against which these “vaccines” were supposed to protect.

Swissmedic, or the persons acting on its behalf, are primarily responsible for the violation of human health already caused by mRNA-based substances and for the ensuing threat.

By law, Swissmedic is tasked with protecting the health of the Swiss population against ineffective or harmful medicinal products. According to the Swiss Therapeutic Products Act (TPA), it is obliged, on the one hand, to ensure that only high-quality, safe and effective therapeutic products are placed on the market. On the other hand, it must protect consumers of therapeutic products against fraud in this context (Art. 1 TPA). Other clear legal obligations as well as these were repeatedly and significantly not fulfilled by those acting on behalf of Swissmedic to the detriment of the injured persons making a report, which is why they have been under urgent suspicion from December 2020 until today.

• given that they, in the context of authorization, manufacture and batch testing and import, repeatedly breached the due diligence requirements under therapeutic products law.

• by granting a “temporary” marketing authorization for various mRNA-based preparations reserved only for special emergency situations in accordance with Art. 9a TPA for various mRNA-based preparations without need, maintaining them permanently and extending their scope of application to all age groups, although it was already adequately proven at the time of the initial authorization that a COVID-19 infection was neither “life-threatening” nor “debilitating” for the healthy population under 65 years of age within the meaning of the Therapeutic Products Act (and that even for those over 65 years of age a conspicuous mortality rate could only be established during short phases in 2020 – albeit without any evidence of a causal link with SARS-CoV-2

• by granting this de facto emergency authorization under Art. 9a TPA without actual need, maintaining this de facto emergency authorization permanently and extending its scope of application to all age groups, although suitable alternative treatment protocols were already available in the course of 2020 (N 1104 ff.),

• by granting – within the meaning of the TPA – the authorization of the mRNA “vaccines” under “temporary authorizations” in accordance with Art. 9a TPA despite the lack of sufficient proof of effectiveness, despite massive indications of risk and despite the absence of a life-threatening or debilitating disease for the population as a whole,

• by massively undercutting the already very low safety requirements applicable to the procedure under Art. 9a TPA, outside of the scope of their dutiful discretion instead of respecting the mandatory and otherwise usual requirements of the ordinary authorization procedure under the guise of “pandemic authorizations”, thereby creating additional risks to public health that had never before been posed by a medicinal product,

• by, instead of carrying out a comprehensive risk-benefit analysis (N 807 ff.) and immediately revoking the authorizations or at least allowing the granted authorizations to expire, renewing their decision to act at the end of 2022 (i.e. having long since been against their better judgement) and perpetuating the new, still experimental mRNA therapy/prophylaxis from 2023 in the sole interest of the manufacturers as a new platform for broad-based use by means of allegedly “ordinary” authorizations,

• by not only permanently withholding key information from the public and the medical profession on the minimal to non-existent protective effect of the mRNA “vaccines” and on the actual risks of side effects, but also by permanently and systematically disseminating misleading information on these issues,

• of having failed to fulfill the obligation to monitor the product after marketing authorization (so-called “pharmacovigilance”) in a manner that was proportionate to the risks involved, and instead seriously and permanently violated the obligation to provide notification of side effects under therapeutic product law (Art. 87 para. 1 lit. c TPA),

• of having seriously violated the prohibition on the advertising of medicinal products under therapeutic product law (Art. 87 para. 1 lit. b TPA),

• of having fulfilled the relevant elements of the Criminal Code ( N 1457 ff.) with respect to the undesirable side effects (death, damage to health) that were foreseeable from the authorization studies and then occurred after authorization,

• of having knowingly and persistently misled both the public and medical professionals in a criminal manner about facts that are essential for the risk-benefit assessment when making a vaccination decision (in particular: forgery of a document by a public official, Art. 317 SCC, N 1198 ff., 1427 ff.; see also ER N 1964 et seq., in particular).

Criminal acts performed by Swissmedic

Initial authorization that breaches the law and duties

The breaches of the law and duty of due diligence objected to here essentially consist of the fact that the authorized persons acting on behalf of Swissmedic provisionally authorized mRNA medicinal products for preventive purposes “on a temporary basis” within the meaning of Art. 9a TPA, although Swissmedic must have been aware of countless risk factors as early as December 2020, each of which would have individually stood in the way of granting a “temporary” authorization until the corresponding risk factors had been thoroughly clarified and eliminated under normal circumstances. The following should be emphasized at this point (for information on many other risk factors, see N 1291 ff.):

• The mRNA COVID-19 vaccines are based on the same mode of action as gene therapies and have therefore been categorized by regulators such as Swissmedic and the European Medicine Agency (EMA) as well as by the manufacturers themselves as an “Advance Therapy Medicinal Product” (ATMP), which poses a particular risk for the following reasons:

  1. Until the end of 2020, mRNA technology had only been used in cancer patients at the pre-mortem stage, i.e. only to combat an existing life-threatening disease, but

    had never before been used purely prophylactically to immunize an entire healthy

    population (N 186 ff.; ER N 62, N 67 ff.). Compared to all other medicinal products

    that have been authorized to date, either on an ordinary or “temporary” basis, the

    authorization of this mRNA technology as an alleged “vaccine” for healthy people is completely unprecedented and therefore represents a considerable risk.

  2. The mRNA technology used here is characterized by the fact that the production

    process of the actual immunizing active substance (active pharmaceutical ingredient = the spike protein) is transferred into the human body. The end product of this internal “vaccine production” is completely unknown in terms of dosage and quality. To date, there is still not sufficient empirical data available to show that the body’s own production of the spike protein can be controlled: (1) quantity of endogenous production; (2) duration of spike production; (3) location of production in the body (affected organs; (4) quality of the proteins produced; and with regard to (5) effectiveness and safety of the active substance produced for a healthy population treated purely prophylactically. The administration of a substance that proves to be uncontrollable with regard to all pharmaceutically relevant parameters must by definition be deemed an experiment on humans.

  3. Both the Federal Office for the Environment and Swissmedic were aware of the particular problems associated with mRNA substances and recognized that these mRNA active substances are gene-modified organisms

    (GMOs/GMMOs) and Advanced Therapy Medicinal Products (ATMPs). In doing

    so, they implicitly recognized that both the Gene Technology Act must be observed and that, above all, the authorization of these products following the simplified authorization procedure would have been ruled out.

• In addition, Swissmedic abandoned the requirements for a standardized dosage of the (mRNA) preparations authorized for injection that are otherwise mandatory for all other medicinal products. For example, Swissmedic accepted an mRNA content per dosage in an arbitrarily wide range of 37% – 126% of the amount of active substance formally declared by the manufacturer, disregarding the most basic standards. Swissmedic thus accepted the corresponding risks of a high proportion of non-intact mRNA and a considerable risk of genotoxicity and carcinogenicity. The same applies to other toxic impurities such as nitrosamine and benzene.

• The manufacturing process for the mRNA products actually administered (“manufacturing process 2″ with plasmid DNA) differed fundamentally from the manufacturing process used for the products authorized by Swissmedic (“manufacturing process 1″) and the general public only became aware of this at the end of 2023 (while Swissmedic had known since the end of 2020). The products administered from manufacturing process 2 show a scandalously high level of bacterial self-replicating DNA impurities (so-called “plasmids”), such that all products made according to manufacturing process 2 should be regarded as “never authorized” as a consequence. However, Swissmedic tolerated this additional massive risk factor without informing the public and without suspending the mRNA authorizations.

• Initial animal studies – a mandatory prerequisite for clinical phase 2 and 3 trials and a key safety element – had not been carried out by the manufacturers at all or not to a sufficient extent, but they already showed disquieting results, for example with regard to the accumulation of toxic lipid nanoparticles.

• The subsequent studies on humans, on the basis of which the “temporary” authorizations were granted at the end of 2020, had only run for two months (instead of the usual 12–24 months) and were then de facto discontinued by the manufacturers by disbanding the control groups and were largely stripped of their medium and long-term significance.

Despite this alarming initial situation from a safety perspective, within the meaning of Art. 1 and Art. 3 of the Therapeutic Products Act, and despite numerous other circumstances that increased the risk, the first authorization of the mRNA “vaccines” was well and truly rushed through by Swissmedic. The applications for authorization were “reviewed” and approved in just 63 calendar days (an ordinary procedure would take 330 days, a procedure for “temporary” authorization usually takes 140 days), whereby important, mandatory, milestones were simply omitted.

As a result, these “temporary” authorizations within the meaning of Art. 9a TPA mean in actual fact that the entire Swiss population participated without their knowledge in the riskiest and largest clinical experiment ever to be conducted in Switzerland (and, by extension, the whole world). And this experiment has not been terminated to date (regarding the experimental character N 843 ff.).

Perpetuation of illegal authorizations that breach the law and duties

Disregard for all additional indications of risk

Without adequately addressing this immense risk created by Swissmedic itself (through the “temporary” authorization) and without at the very least informing the public of all the risks, Swissmedic proceeded unperturbed in June 2021 to extend its authorizations to adolescents aged 12 and over. This occurred although, in addition to all the other facts up to mid-June 2021 which increased the risk and were therefore legally relevant, it was known

• that regulatory authorities such as Swissmedic were flying completely blind due to a lack of strict batch testing and thus a lack of sufficient quality controls,

• that the dose authorized for adolescents was two times (Comirnaty) or five times (Spikevax) higher than the recommended dose, meaning that Swissmedic accepted an additional and again completely unnecessary risk among adolescents, an age group that was at no time seriously at risk during the pandemic year 2020 – i.e. just from COVID-19 without having been “vaccinated”,

• that according to Pfizer’s Post Marketing Pharmacovigilance Report, a total of 42,086 side effects and over 1,200 deaths had been reported for Comirnaty alone by February 2021 – i.e. within two and a half months, which should have led to the immediate termination of the trial,

• that according to this damning Pfizer report, as many as 13% of breastfed infants were affected by side effects and even Pfizer had identified a negative impact on male fertility as a potential risk,

• that, according to global adverse event reports, the alarm threshold of 50 deaths had already been exceeded by a factor of 150 by June 2021,

• that the COVID-19 “vaccines” had already proven in May 2021 to be significantly more dangerous than the flu, swine flu and measles vaccines– that were commonly administered up to that point – in view of the large numbers of adverse event reports.

Even these scandalous alarm bells did not prompt Swissmedic to seriously question the wrong path it had taken. Swissmedic neither limited the number of authorizations nor informed the public about the risks identified. Swissmedic did not even feel compelled to improve its own purely passive pharmacovigilance by recording the side effects identified in Switzerland. Instead, at the end of 2021, Swissmedic took the step of extending the authorizations to a third dose (“booster”) and to children aged five and over, even though this youngest age group was not seriously at risk at any time during the pandemic year 2020 – i.e. from COVID-19 alone without having been “vaccinated” – and although by this point among other things (for information about many other risk factors) it was also known,

• that even representatives of the pharmaceutical industry were openly describing mRNA injections as what they really are – a form of gene therapy,

• that the toxic spike protein produced in the body of the vaccinated person is present in the body for much longer and in a much higher concentration than originally stated by Swissmedic and the manufacturers, which can lead to a number of serious side effects (including death),

• that data had been falsified and risk signals concealed in the context of the Comirnaty authorization study (Pfizer/BioNTech) (N 397 ff.), which should have led to the immediate withdrawal of the study,

• that Pfizer/BioNTech had presented an alarming interim report (PSUR) at the end of August 2021, according to which 46 cases had ended fatally in the clinical trials and 5,069 cases (1.6%) had already ended fatally in the so-called “postmarketing phase”, which under normal circumstances should have led to an immediate revocationof the marketing authorizations,

• that Pfizer had delivered 7 batches with a massively increased number of adverse event reports to Switzerland – an alarm bell that should have led Swissmedic to immediately warn the population and even to recall the batches, but this has not yet happened,

• that at least 60 deaths were recorded of children in Switzerland, the EU and the USA for Comirnaty and Spikevax alone (N 438 f.), which means that the absolute alarm threshold of 50 deaths was clearly exceeded in this target group alone, which is in no way at risk from SARS-CoV-2, which should have led to the immediate suspension of this authorization extension at least, if not the suspension of all mRNA authorizations,

• that more than 2,000 premature births and stillbirths following mRNA injections had already been reported in the USA and the EU alone,

• that a worrying trend was already evident in Switzerland in 2021, namely a conspicuous and persistent death rate in younger age groups a short time after “vaccination activity”,

• that the mRNA “vaccines” (Comirnaty and Spikevax) had received 60 times as many reports of serious side effects and 20 times as many reports of deaths per million doses administered in comparison with the influenza vaccines by the end of 2021.

Instead of finally suspending the mRNA authorizations, carrying out an in-depth analysis of the decisions taken, telling the public the truth about the risks that can actually be identified and improving the reporting system for recording vaccination side effects in line with these risks, Swissmedic continued to maintain all “temporary” authorizations in 2022. This occurred although, in addition to all the existing facts with risk and legal relevance (for information on many other risk factors, see N 1311), it was known

• that mRNA products belong to the group of ATMP high-risk products because “they contain nucleic acid, regulate gene expression and, as ‘biologically active material’ (i.e. RNA), are treated in the same way as genetically modified organisms (GMOs)”, which even Swissmedic recognized,

• that for this reason alone and also in accordance with Art. 12 para. 5 lit. c and lit. e of the Ordinance of the Swiss Agency for Therapeutic Products on the Simplified Authorization of Medicinal Products and the Authorization of Medicinal Products in the Notification Procedure (Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung von Arzneimitteln und die Zulassung von Arzneimitteln im Meldeverfahren; VAZV, SR 812.212.23), a temporary authorization under Art. 9a TPA was unlawful from the outset (see 530, N 916 ff., N 992 ff.),

• that almost four million adverse reactions to all COVID “vaccines” had already been reported worldwide (Switzerland, EU, USA) by May 2022 (N 538 ff.), with Comirnaty and Spikevax alone accounting for over 1.7 million reports, including 464,971 serious adverse reactions and 20,886 deaths (N 548 ff.), exceeding the alarm threshold of 50 deaths worldwide over 400 times at that time, and that these figures continued to rise,

• that an alarming interim report on Comirnaty had once again been published by Pfizer/BioNTech (“PSUR No. 3″), from which it emerged

  1. that under 50-year-olds were excessively subject to side effects, i.e. a population group only minimally affected by COVID-19,

  2. that guidance on the safe use of Comirnaty for pregnant women, breastfeeding

    mothers and other patient groups was still lacking,

  3. that there had been massive differences in quality between the individual batches

    and that many dangerous batches had once again been delivered to Switzerland,

• that despite Swissmedic’s statements that the mRNA “vaccines” had no effect on pregnancy, there were reports, without taking underreporting into account, of 2,135 stillbirths after vaccination with Comirnaty and 798 stillbirths after vaccination with Spikevax as well as 5,055 miscarriages after all COVID-19 “vaccines” by May 2022 in the EU and the USA alone, with the manufacturers still openly admitting in 2022 that, due to a lack of corresponding studies, “the safety profile of the vaccine in pregnant or breastfeeding women is not known”,

• that there was a historic decline in live births amounting to 8.5% across the world and also across Switzerland in 2022, for which mRNA injections remain the only plausible cause after excluding all other hypotheses,

• that, according to a study on male fertility published in June 2022, sperm concentration 150 days after the second “vaccination” was still 15.9% below the initial value, which means that not only female fertility but also male fertility might be significantly negatively affected by the “vaccination”,

• that an in-depth analysis of the FSO data by Professor Konstantin Beck revealed a conspicuous and persistent mortality rate in all age groups a short time after “vaccination activity”,

• that based on the FSO data in Switzerland, there has been a significant increase in a wide variety of disease diagnoses, especially within age groups not threatened by COVID-19 in any way (damage to the nervous system: +29%; cancer diagnoses: +48%; pregnancy complications: +25%; pulmonary embolism, cardiac arrest, stroke and cerebral infarction in 0 to 14-year-olds: +125%) since the start of the “vaccination campaign”,

• that, according to several autopsy results, the “vaccine” spike protein was proven to be the cause of death and that, contrary to Swissmedic’s official statements, it is not only detectable in the human body for a short time, but for up to nine months,

• that the occurrence of myocarditis in connection with a COVID-19 mRNA injection, which can be fatal in the worst cases, is, according to a study from Basel that has now been peer-reviewed, much more frequent and up to 800 times more frequent than officially reported by the regulatory authorities (N 674 ff.),

• that with VAIDS , a serious side effect that has been suspected to exist for a long time and has been increasingly recognized since 2022 has become apparent, which constitutes damage to the immune system, which can lead not only to an increased onset of autoimmune diseases and cancer, but above all to an increased onset of infectious diseases – and, in particular, also to a greater susceptibility to COVID-19 infections (“Long COVID”),

• that by 1 March 2022, at least 128 peer-reviewed publications on heart problems, 216 peer-reviewed publications on life-threatening coagulation disorders (thromboses, etc.) and six peer-reviewed publications on possible deaths as a result of COVID vaccinations have been published.

With the “temporary” authorization of the mRNA “vaccines”, Swissmedic therefore accepted an unprecedented and steadily increasing risk to public health. At best, this could only have been justified by the fact that it could have averted an unprecedented threat (from SARS-CoV-2) and in doing so outweighed the exceptionally high risk associated with the mRNA “vaccines”. This is clearly not the case.

Absence of a “life-threatening or debilitating” disease

“COVID-19″ is not and has never been a “life-threatening or debilitating” disease that threatens the public at large, this being the key prerequisite for the “temporary” authorization.

With an infection fatality ratio (IFR) of 0.15%–0.20%, COVID-19 was already discernibly no more dangerous than moderate influenza at the end of 2020; there was no historically conspicuous excess mortality in relation to the overall population and hospitals were never overcrowded. Continues….



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  • Anonymous

    The fact that there has not been a single arrest for this modern Holocaust can only mean that law enforcement has been infiltrated and compromised. I have never seen so many young people dropping like flies.

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