5 Apr 2022 21:01
Very early on, in May 2020, several laws and regulations for corona vaccines were repealed by the Merkel government under the then Minister of Justice Lambrecht. These were due to expire in May 2022, but were renewed again on March 9th.
First the blog reported Communitas Bonorum At the end of February about the rather unknown fact that the federal government, via the responsible Federal Ministry of Justice, had already modified elementary laws, ordinances and regulations in force up to now in May 2020 regarding the existing “Medical Needs Supply Assurance Ordinance (MedBVSV)”.
Under the government leadership of Angela Merkel at the time, the responsible minister was today’s Defense Minister Christine Lambrecht (SPD). Another one that happened recently noticecommented the publicist and professor for European politics at the University of Bonn, Ulrike Guérot, with the statement:
The groundbreaking, i.e. elementary, changes relate to the “regulation to ensure the supply of the population with products of medical need in the epidemic caused by the coronavirus SARS-CoV-2 (Medical Need Supply Assurance Ordinance – MedBVSV)” of May 25, 2020. In an older version the note can be found: “Medical needs Supply Assurance Ordinance of May 25, 2020 (…), which was last amended by Article 9 of the law of July 27, 2021 (Federal Law Gazette I p. 3146). The Ordinance takes effect in accordance with § 10 of this V (…) of May 28, 2021 (…) expires on May 31, 2022.” Since March 10, the regulation has now been extended again:
“This ordinance will come into effect the day after promulgation. It will expire on November 25, 2022.”
Due to the complexity of legal formulations, only the decisive points are named and the wording that is valid in each case is listed. § 3 para. 1 and § 4 of the modified MedBVSV refer to the COVID-19 vaccines and significantly change what was previously valid Medicines Commerce Act – the Medicines Act (Section 99), the Transfusions Act (Section 138 – eleventh subsection) and the Ordinance on the Production of Drugs and Active Substances (Sections 13-20a). The marked emphasis in the quotations serve the overall understanding of the scope of the changes decided in the MedBVSV:
“The higher federal authority responsible according to § 77 AMG can order in individual cases that, contrary to § 8 paragraph 3 AMG, medicinal products whose expiry date has expired may be placed on the market if this is necessary to ensure the supply and it has made sure that that the quality, effectiveness and safety of these medicinal products are not significantly impaired.”
“The higher federal authority responsible according to § 77 AMG can order in individual cases that, contrary to §§ 10 and 11 AMG, medicinal products may be placed on the market without labeling and package leaflets if this is necessary to ensure the supply of medicinal products.”
“Deviating from § 84 AMG, pharmaceutical companies, manufacturers and health professionals are not liable for the effects of using the products mentioned in § 1 paragraph 2 if these products are used by the Federal Ministry in response to the suspected or confirmed spread of SARS-CoV -2 pathogen are placed on the market.”
The business journalist Norbert Häring provides an up-to-date report on these modifications items states: “Since this paragraph does not apply to corona vaccines, the pharmaceutical company is not liable for serious vaccination damage if used properly. Corona vaccines do not have to be accompanied by specialist information and instructions for use anyway.”
“Pharmaceutical entrepreneurs, manufacturers and health professionals are only responsible for the consequences of deviations from the Medicines Act based on paragraph 1 in the event of gross negligence or intent.”
In his article, the business journalist assesses potential follow-up scenarios on this point as follows: “If the vaccinations should cause serious damage due to the numerous exceptions to quality assurance and testing requirements, neither the manufacturer nor the vaccinating doctors or pharmacists are liable.”
“(…) §§ 73a, 78 and 94 of the Medicines Act (AMG) and § 4a paragraph 1 and § 6 paragraph 1 of the Medicines Trade Ordinance (AM-HandelsV) do not apply to the Federal Ministry, the bodies commissioned by it and to persons , from which the Federal Ministry or an agency commissioned by it procures the medicinal products.”
The law on the sale of pharmaceuticals defines “Prices” in section 78 under point 1: “The Federal Ministry for Economic Affairs and Energy is authorized, in agreement with the Federal Ministry, by statutory order with the consent of the Bundesrat – 1. Price ranges for pharmaceuticals that are sold wholesale or be dispensed in pharmacies for resale, … to fix.” Conversely, this means that the pharmaceutical industry has, in writing, received sole sovereignty over price determinations and price ranges for COVID-19 drugs from the federal government.
“The authority responsible for monitoring the marketing of medicinal products according to Section 64 AMG can, in individual cases, permit the placing on the market of medicinal products that deviate from Sections 13 to 15 and Section 19 AMG or from Sections 3, 4, 11, 15 , 16 and 17 or Sections 22 to 26 of the Ordinance on the Production of Medicinal Products and Active Substances (AMWHV), …”
The law on the trade in medicinal products defines “areas of responsibility” in Section 19: “The qualified person according to Section 14 is responsible for ensuring that each batch of the medicinal product has been manufactured and tested in accordance with the regulations on the trade in medicinal products.” Conversely, this means that COVID-19 vaccines (medicines) could theoretically be manufactured – “permitted” – without a competent person.
With regard to an ongoing discussion, based on the still incomplete final scientific knowledge, how the new mRNA vaccines will affect vaccinated citizens in the coming years, nevertheless, in May 2020, deviating from “§ 5 paragraph 1 sentence 2 of the Transfusion Act (TFG) and of the guidelines of the German Medical Association for the collection of blood and blood components” that “the Paul-Ehrlich-Institut is authorized, adjusted in agreement with the Robert Koch Institute and with the consent of the Federal Ministry”, “in deviation from § 5 … of the TFG suitability – to establish eligibility and deferral criteria for whole blood, blood components and plasma donors”.
Under § 1 (purpose of the updated regulation and definitions, which are now valid until November 25, 2022), it says: “This regulation serves to ensure the supply of the population with products of medical necessity during the epidemic caused by the coronavirus SARS-CoV-2. Federal Ministry within the meaning of this regulation is the Federal Ministry of Health. It can be assumed that the federal government will consider a further extension.
Business journalist Häring summarizes at the beginning of his article: “In December 2021, Federal Minister of Health Lauterbach ordered millions of doses of vaccine because it was said to have been necessary for the booster campaign, which was not true. The total purchases by the federal government in 2021 totaled 554 million doses, enough for every German citizen almost seven times Since vaccination activity has dropped sharply and most vaccines only have a shelf life of around six months, doses are gradually reaching and exceeding the intended use-by date in large numbers.”
Neither Minister of Health Jens Spahn nor Minister of Justice Christine Lambrecht under Chancellor Merkel, Minister of Health Lauterbach or Minister of Justice Marco Buschmann of the current traffic light coalition had or have to date feared even the slightest consequences for the decisions made.
More on the subject – Berlin doctor accuses: “Compulsory vaccination would open the door to abuse wide”