The planned changes to the Drugs Act and the Genetic Engineering Act in Austria (Report24 reported) are currently causing a stir. According to experts, the changes not only undermine drug safety: the law apparently also serves to legitimize mass vaccinations with the experimental and only conditionally approved Covid vaccines and paves the way for mandatory vaccination.
You can still go to the Parliament’s website until January 10th Opinions be brought against the law. To date, more than 29,600 comments have been received. Each of these can be supported by consent. The opinion with the most approvals so far is that of a pharmacist from Innsbruck, who explains in detail five points of criticism of the changes in the law. She also sees a clear connection between the draft legislation and the Covid vaccination campaign.
She starts hers opinion with the words:
From my point of view as a responsible pharmacist, this current government proposal to amend the Medicines Act (AMG) and the Genetic Engineering Act (GTG) is to be rejected in its entirety, because it shows the government’s great irresponsibility with regard to the health of citizens in the context of application, clinical testing and drug monitoring.
According to the opinion, the safety and health protection of users of medicinal products will be undermined by the changes in the law. The pharmacist sees this as an attempt to create the conditions for the planned mandatory vaccination and criticizes the fact that in this way the widespread use of the experimental Covid vaccine is apparently also supposed to be legitimized retrospectively. She regards this as extremely problematic from a legal point of view.
For them, one thing is certain: the changes in the law are jeopardizing drug safety in Austria as a whole.
The following are the five points of criticism from the opinion Literally quoted (emphasis by Report24):
1 With regard to the necessary safety of medicinal products in humans, it is extremely questionable if essential due diligence, data protection and safety provisions in the Medicines Act in the context of clinical studies and tests are deleted without replacement. This applies in particular to those paragraphs that deal with the protection of certain groups of people such as pregnant women (Section 44 AMG) or minors (Section 42 AMG). Furthermore, in the context of clinical trials and medical experiments (such as in the course of the further roll-out of the still experimental Covid-19 vaccination strategy), currently applicable safety regulations, in particular the reporting and testing of serious side effects up to disabilities and deaths of test persons, no longer have to be in the previously strict form.
2 Furthermore, it is questionable and even less in the sense of the greatest possible drug safety that parallel to this the compliance with the regulations on clinical trials in the Genetic Engineering Act (§§ 74-78a), which was previously prescribed in the Medicines Act, is no longer applicable. In the future, according to the draft law, research and therapy can be carried out on humans (including with GMO therapeutics) without any fundamental statutory restrictions and safety requirements. This is irresponsible!
3 In the sense of the precautionary principle and the health protection of people who are exposed to the use of drugs or vaccines, it is therefore to be rejected if, instead of the deleted legal basis in the Drugs and Genetic Engineering Act, in the future an (allegedly) independent ethics committee solely on use, application and therapy of drugs and vaccines up to GMO therapeutics should decide (§ 32 AMG). This opens the door to arbitrariness and influence, because no body can be influenced, no body has leased the truth for itself, and without a corresponding legal basis as to what this commission has to observe and how deeply it is to be examined, the discretion of such a commission is intolerable large. Citizens are becoming increasingly poorly protected guinea pigs in pharmaceutical laboratories.
4 It is incomprehensible and also highly risky that the government bill provides that the use of genetically modified organisms (GMOs) on humans should be less strict than those for seeds and food.
Because in the Genetic Engineering Act, according to the draft, the term “gene therapy” is now to be expanded to include the “application of genetically modified organisms (GMO) for therapeutic purposes” (in the case of vaccines also to healthy people!) And at the same time the rules for clinical testing that have been customary up to now ( §§ 74-78a GTG) and the previously common state control (§ 101 GTG) will be deleted.
These GMO therapeutics, which are also not clearly defined in the legal text, should therefore be able to be produced and used in the future without (!) State controls (§ 101 GTG new), although precisely these technologies are frowned upon in agriculture and food production (e.g. GM maize) and are strictly there controlled by the state and the release into the environment monitored (Section 101 still in force).
5 It is not in the interest of the health and safety of the population (to which the government is obliged) that the government and pharmaceutical companies can keep themselves harmless by means of the new § 40 AMG, in which the sponsor is obliged to take out personal injury insurance for test participants, regardless of fault (§ 1295 ABGB) all damage to the life and health of the test participant caused by the clinical trial measures carried out on him, with the exception of damage due to reasons of changes in the genetic material in cells of the germ line. So the biggest unforeseeable, long-term risks are not covered. That is irresponsible!