Vaccines against Covid-19 : the laboratories are they exempt from the financial responsibility in the case of adverse effects ?

So that the vaccination campaign is accelerating in France, after several weeks of trial and error, the question of the responsibility of the laboratories in the event of side effects related to vaccines against the Covid-19 often comes up in debates. The president of the national Rally (RN), Marine Le Pen, denounced, as early as November, " a clause that indicates that if there are adverse effects or harmful, the european Union agrees not to go to law against the manufacturer of the vaccine ".

This accusation is repeated on the social media publications alleging that the manufacturers would be cleared of all responsibility in the event of adverse effects of their products. The site Réinfo Covid, which brings together a group of health care providers and scientists popular among the " covidosceptiques ", has advanced this argument in the beginning of January in a note on the vaccine Pfizer-BioNTech. According to the group, " laboratories have been exempt from the financial responsibility in the event of an adverse reaction by the european Union ".

REINFOCOVID.FR

If laboratories have attempted – successfully in the United States – to avoid possible legal action, they will not necessarily be exempt from any legal liability or financial in France.

Read our decryption : how are vaccines effective ? What are the side effects have been observed ? Our answers to your questions financial guarantees, but a responsibility, which "is always the company's"

This is not France directly, but the european Union, which is negotiating supply contracts with manufacturers of vaccines for all member States. To date, the EU has signed six contracts with laboratories AstraZeneca-Oxford, Pfizer-BioNtech, Moderna, Sanofi, GSK, Johnson & Johnson and CureVac. Only two vaccines, Pfizer and Moderna, they got a green light from the health authorities to be prescribed in Europe.

The negotiations with the laboratories are not made public. Impossible to know the details of the agreements. The european Commission has, however, provided some of the items relating to liability and compensation. She recalls that the contracts are concluded in accordance with the rules of the EU, which would " require that this responsibility always lies with the company : if a product is defective, it is the laboratory that is responsible.

The financial guarantees, however, have been granted to manufacturers, because of the original production of vaccines, the bit about possible side effects (the development of a vaccine usually takes place about ten years), and risk incurred by the laboratories :

" The CAA [purchase contracts early] provide that the member States shall compensate the manufacturer for any liability incurred only under the specific conditions defined in the CAA. "

clearly, In the case of legal proceedings against laboratories, the EU can contribute to the compensation under the conditions specified in the contract. In November, the minister in charge of industry, Agnès Pannier-Runacher, stated :

" The only cases in which the EU could potentially share the load, (...) what would be the occurrence of an episode that would be harmful and not known, neither by us nor by the pharmaceutical laboratory, (...) and for which the laboratory can demonstrate that at every moment he has been transparent. "

In the contrary case, according to the minister, any negligence proven a pharmaceutical laboratory " would obviously be before the courts with a compensation at the expense of the pharmaceutical laboratory ".

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That said precisely the right european relied on ? The EU is based on a directive, 1985, " on the approximation of the laws, regulations and administrative provisions of the member States concerning liability for defective products ". Transposed into French law in 1998, this responsibility is governed since 2016 by sections 1245 1245-17 of the civil code.

According to this directive, the laboratories are responsible in case of faults or negligence related to the product, unless they prove " that the state of scientific and technical knowledge (...) did not detect the existence of the defect ". The text also specifies that the vaccine manufacturers may not impose a clause waiving any and all liability. It is "contrary to the law," recalled Ms. Pannier-Runacher.

This directive was at the heart of a decision of justice major in 2017, opposing a patient with multiple sclerosis laboratories, Sanofi Pasteur and GlaxoSmithKline (GSK). The Court of justice of the european Union had made the laboratories responsible for the disease by the patient vaccinated against hepatitis B. The Court had held that in the absence of a scientific consensus, " the absence of a vaccine and of a causal link between it and a disease that can be proven by a beam of indices serious, precise and concordant ".

A compensation fund in France, where appropriate

In case of damage due to a vaccine, and when "the responsibility is not attributable to the laboratories," the cabinet of Agnes Pannier-Runacher, contacted by The World, reminds us that there is a public organization under the supervision of the ministry of health that allows to compensate the victims : the Office national d'indemnisation des accidents médicaux (Oniam).

An individual, the victim of an accident related to the administration of a vaccine can enter the Oniam by sending a request for compensation. "It is a mutual agreement procedure, fast and free to allow victims of compulsory vaccination to obtain redress without going through a judicial process," details the organization on its website.

The fund is only available for mandatory vaccinations. However, emergency measures may be taken in the event of an outbreak. An outstanding feature was put in place in the context of the influenza A (H1N1) in 2009 and 2010, to enable victims of vaccination to obtain redress. To the World, the ministry of health has confirmed that he would be the case also for potential medical accidents related to the campaign of vaccination against Covid-19, which started in late December in France. A causal link " between the administration of the vaccine and the injury must be established." This supported "does not mean, however, however, not the health professionals of all responsibility," said the ministry.

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