The claim

A video contribution and an accompanying article from a Swiss sect claim that many consumer protection measures have been removed for the corona vaccines.

Our conclusion

That's not true, they were only included in a new, time-limited regulation for the vaccines, compliance with which is not the responsibility of the federal government, but of the Paul Ehrlich Institute.

Since the beginning of the corona pandemic, the format “Klagemauer TV” (Kla.tv), which belongs to , has repeatedly spread false claims about SARS-CoV-2 and the vaccines.
A short video from the channel is now intended to show that many consumer protection measures in the Medicines Act have been deleted for the corona vaccines. But that's not true, they were only included in a new, time-limited regulation for the vaccines, compliance with which is not the federal government, but the Paul Ehrlich Institute.

The claims

The video with the allegations is shared on Facebook and Telegram , and the false claims are also circulating as a sharepic:

Sharepic with the false claims about the drug law
Sharepic with the false claims about the drug law

The following claims are made:

  • Expired corona vaccines may also be placed on the market (§ 8, paragraph 3)
  • Corona vaccines no longer need to be labeled and do not require an information leaflet (§ 10, 11 and 11a)
  • Batches are no longer subject to state quality control (§ 32)
  • Manufacturers no longer have to set aside money for damage caused by corona vaccines (§ 94)
  • Drug manufacturers, doctors and pharmacists are not liable for possible consequential damage caused by the corona vaccination; no one is liable (§ 84)
  • Section 5 of the Transfusion Act has been weakened and vaccinated people are now allowed to donate blood at any time

Let's go through the legal texts below, because it quickly becomes clear that the respective legal texts have only been half read.

What the video and sharepic are based on

Ordinance to ensure the supply of medical products to the population in the event of the epidemic caused by the coronavirus SARS-CoV-2 was issued on May 25, 2020 (see HERE ). This includes, among other things, the procurement and distribution of medical supplies and exceptions.

The makers of the video cherry-picked a few things from this regulation, but did not read them completely. In the following paragraph, the paragraphs that were picked out are printed in bold, the text in italics shows what was left over. This is what it says in § 3, paragraph 1:

§ 8 paragraph 3 , §§ 10, 11, 11a and 21 paragraph 1, § 21a paragraph 1 and 9, § 32 paragraph 1 , §§ 43, 47 and 72 paragraph 1 and 4, § 72a paragraph 1, § 72b paragraphs 1 and 2, § 72c paragraph 1, §§ 73a, 78 and 94 of the Medicines Act (AMG) as well as § 4a paragraph 1 and § 6 paragraph 1 of the Medicines Trade Ordinance (AM-HandelsV) do not apply to the Federal Ministry commissioned bodies and for persons from whom the Federal Ministry or a body commissioned by it procures the medicinal products, if the Federal Ministry or a body commissioned by it procures medicinal products or active ingredients, starting materials and auxiliary substances and places them on the market in accordance with Section 2 Paragraph 1.

Important: “ …if the Federal Ministry or a body commissioned by it […] procures the medicines and puts them on the market ”.

This means that the paragraphs have not been deleted, but simply do not apply to the Federal Ministry, as a commissioned body takes over these tasks.

However, we will discuss individual points of the allegations further below.

The commissioned body

Who this commissioned body should be can also be found in the Medicines Act § 77:

“The responsible higher federal authority is the Federal Institute for Drugs and Medical Devices, unless the Paul Ehrlich Institute is responsible. The Paul Ehrlich Institute is responsible for sera, vaccines , blood preparations, tissue preparations, tissues, allergens, drugs for advanced therapies, xenogeneic drugs and genetically engineered blood components.”

So it is clearly regulated that the Paul Ehrlich Institute is responsible for vaccines, and has been for the whole time. However, this was explicitly mentioned again in the regulation, as there are also other deviations about which regulations were made.

Some examples

Of course, the Paul Ehrlich Institute is not allowed to do things as easily as they please; they are also bound by the law. The fact that the makers of the video don't really know the paragraphs is evident right from the first statement.

Expired vaccines and batch testing

Apparently Section 8, Paragraph 3 of the Medicines Act has been deleted. It states that it is forbidden to market medicines whose expiry date has expired. , Section 4, Paragraph 2 of the “ Medical Needs Supply Guarantee Ordinance ” states :

“The higher federal authority responsible under Section 77 AMG can order in individual cases that, in deviation from Section 8 Paragraph 3 AMG , medicinal products whose expiry date has expired may be placed on the market if this is necessary to ensure supply and it has made sure “that the quality, effectiveness and safety of these medicines are not significantly affected .”

Expired vaccines may actually be used (e.g. if there is an acute shortage of vaccines), but quality, effectiveness and safety must be ensured.

And the Paul Ehrlich Institute is responsible for this (see HERE , point: batch testing), which immediately refutes the claim that the vaccines are no longer subject to quality control.

Instructions and labeling

There is also a regulation for this that applies in exceptional cases, for example if there is no time to prepare labels and leaflets because a batch is urgently needed, namely in Section 4, Paragraph 1 of the Supply Guarantee Ordinance:

“The higher federal authority responsible under Section 77 AMG can order in individual cases that, in deviation from Sections 10 and 11 AMG, medicines may be placed on the market without labeling and a package leaflet if this is necessary to ensure the supply of medicines . Section 11a AMG does not apply to these medicines. In these cases, the responsible higher federal authority publishes the necessary product information in an appropriate and barrier-free manner.

In individual cases , labels and package inserts may be omitted, but this information must then be published elsewhere in a barrier-free manner, for example on the homepage.

It is therefore wrong that all corona vaccines can now be sold at any time without a label or leaflet.

Liability for any consequential damage

, Section 3, Paragraph 4 of the MedBVSV states that pharmaceutical companies, manufacturers and healthcare professionals do not have to be liable if there is no gross negligence or intent . For example, if it turns out that consequential damage was known but ignored, the manufacturers are certainly liable.

However, it is not true that no one is liable and that you therefore have to bear the costs of any consequential damage yourself. We already addressed this claim in an article (see HERE Paragraph 60 of the Infection Protection Act (IfSG) (see HERE ) regulates:

has suffered damage to their health as a result of a vaccination or through another specific prophylactic measure [...] [...] upon request in accordance with the provisions of the Federal Supply Act, unless this law provides otherwise. “

The respective federal states are liable for consequential damage.

Blood donations from vaccinated people

Nothing changed at all in Section 5 of the Transfusion Act have been found fit under the responsibility of a medical person in accordance with the state of medical science and technology may donate blood .

Regarding blood donations from vaccinated people, the German Red Cross writes :

“Yes, blood can be donated even after a SARS-CoV-2 vaccination approved in Germany. We only recommend that you do not donate blood on the day of the vaccination, but rather the following day. This way you can better differentiate any side effects that may occur. So if you feel fit the day after the corona vaccination, you are welcome to donate blood.”

According to the Paul Ehrlich Institute, blood donation one day after a corona vaccination is possible without any problems (see HERE , PDF file); there are no medical concerns about it. The Bavarian Red Cross's “Blood Donation Service” page (see HERE ) also states that donations can be made just one day after a vaccination - on February 20, 2021, when the vaccinations were just starting!

The claim that the law has now changed is false. It is also wrong that vaccinated people were not allowed to donate beforehand, because it was already clear in the first few weeks of vaccinations that there were no medical concerns about it.

Conclusion

The claims in the video are largely based on a lack of knowledge of the regulations, which leads to false conclusions; in the case of blood donations, they are even completely wrong. Since the channel has been spreading false claims since the beginning of the corona pandemic, it can be assumed that in this case too the information was intentionally omitted in order to be able to spread an alleged scandal.


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Notes:
1) This content reflects the current state of affairs at the time of publication. The reproduction of individual images, screenshots, embeds or video sequences serves to discuss the topic. 2) Individual contributions were created through the use of machine assistance and were carefully checked by the Mimikama editorial team before publication. ( Reason )