Is there really a lab disclaimer?

This is an argument that comes up regularly on the social networks of the most virulent antivaccines: the laboratories would benefit from a blank check from the European Union for their virus. In other words, if serious side effects appeared after inoculation of the vaccine, the laboratories would be criminally irresponsible.

This Sunday, November 15, Marine Le Pen, opposed to compulsory vaccination, said she was “worried” when it exists in vaccine purchase contracts by the European Union “a clause which states that if there are adverse or harmful effects, theEuropean Union undertakes not to go to court against the vaccine manufacturer“.” Illegal “and” immoral “, said the president of the National gathering, sure BFMTV.

This Monday November 16, Agnès Pannier-Runacher, Minister Delegate in charge of Industry affirmed on franceinfo that the contracts being written that the assertion of Marine Le Pen is “inaccurate”, and that even if they provided for it, such a clause would be “contrary to the law”, and that even “if there were such a clause, being contrary to the law, it would be deemed unwritten”. This is in fact what thearticle 1245-14 of the Civil Code.

What the law says

Article 1245 and following of the Civil Code on liability for defective products affirm that “the producer is liable for damage caused by a defect in his product, whether or not he is bound by a contract with the victim” (art. 1245), unless, as the Minister recalled, he proves that “the state of scientific and technical knowledge, when it put the product into circulation, did not allow the existence of the defect to be detected” (art. 1245-10).

Note that European case law provides that, by judgment C-621/15 of the Court of Justice of the European Union, “in the absence of certain and irrefutable evidence, to conclude that a vaccine is lacking and that there is a causal link between it and a disease on the basis of a set of serious, precise and concordant clues, as soon as this body of evidence enables it to consider, with a sufficiently high degree of probability, that such a conclusion corresponds to reality. ”

Any negligence by a laboratory would obviously be in court.

Agnès Pannier-Runacher, Minister Delegate for Industry.

For the exception provided for by article 1245-10, Agnès Pannier-Runacher affirmed that “this already existed for H1N1: in these cases, there are devices, a bit like natural disaster devices, which make it possible to take charge of difficulties and compensation.

In the case of the influenza A (H1N1) vaccine, the National Medical Accident Compensation Office is responsible for these compensations. As indicated his website, this is based on articles L3131 and following of the Public Health Code, which establishes the responsibilities in the event of a “serious health threat”. In the case of H1N1, cases of narcolepsy have been attributed to vaccination.

The Government recognizes that the responsibility of the producer may, in certain specific circumstances, not be engaged.

Delegate Ministry in charge of Industry

At this stage, the compensation could be “shared” in the event of “the occurrence of a harmful episode which would not be known in the state neither by the laboratory, nor by [les autorités], and on which the laboratory could demonstrate that it has been transparent at all times. Any negligence of a laboratory would obviously be before the courts with compensation payable by the laboratories.“, added the Minister Delegate in charge of Industry.

Recalling all this, Bercy confirmed to RTL.fr that “it means that the Government recognizes that the responsibility of the producer may, in certain specific circumstances, not be engaged. But in all cases, the victims are covered. “” The applicable law also takes into account the particularities inherent in health products and in particular the so-called risk of ‘development’ “, justifies the Ministry in charge of Industry.

What the clause on anti-Covid vaccines provides

This is exactly what we find in the contracts for the purchase of vaccines, according to his press releases concerning the purchases of vaccines fromAstraZeneca or Sanofi-GSK, “in order to offset the high risks taken by manufacturers, advance purchase contracts provide for Member States to compensate the manufacturer for liabilities incurred under certain conditions. The responsibility remains with the companies“, still explain these releases.

“The [contrats] expect that Member States compensate the manufacturer for any liabilities incurred only under the specific conditions defined in the [contrats]”, specifies the European Union on his question-and-answer site.

“Consequently, the liability and indemnification provisions do not alter the burden of proof, which is the regulatory responsibility of companies to demonstrate the safety and efficacy of their products, adds the EU. Any vaccine placed on the market will have to meet the required safety requirements and undergo an independent scientific evaluation by the European Medicines Agency as part of the EU marketing authorization procedure. “

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