AstraZeneca vaccine against Covid-19 (illustration). – Massimo Insabato / Mondadori Portf / SIPA
- Are certain laboratories that have sold their anti-Covid-19 vaccine to the European Commission exempt from all liability in the event of unforeseen side effects?
- This is what affirms a viral message on Twitter which takes up the arguments of a Belgian collective.
- If the member states of the European Union can pay any damages decided by the courts in the event of a complaint, the laboratories remain fully liable to the courts.
A little more than a week after the suspension of the AstraZeneca vaccine in several European countries, then its return authorized by the European Medicines Agency (EMA), an alarming message is met with great success on Twitter.
“Belgian lawyers were able to access the 3 vaccine contracts [contre le Covid-19], and their clauses. In the event of damage, the responsibility does not fall on the manufacturers! The governments of the European Union are accomplices! », Supports this tweet, which supports his remarks with an explanatory video produced by Notre bon droit,« an alliance of health professionals, scientists, lawyers and Belgian citizens [estimant] that the government’s response to COVID-19 is misguided. “
Belgian lawyers were able to access the 3 vaccine contracts, in the clauses in the event of damage the liability would not fall on the manufacturers! EU governments are accomplices! #AstraZeneca #COVID ー 19 #Macron pic.twitter.com/IDUYwC2ugo
– The General💎 (@LE_GENERAL_FR) March 23, 2021
With this in mind, the collective commissioned a law firm to provide a legal opinion on the legal value of certain clauses in vaccine ordering contracts signed by the European Commission with AstraZeneca, CureVac and Sanofi. And to believe this study, “In the light of Belgian law of obligations, the clauses according to which vaccine manufacturers do not guarantee and assume no responsibility for the efficacy and the absence of serious adverse effects should, a priori, be considered as being illegal. “
“The purpose of these clauses is to exempt manufacturers from their essential obligation […] but also – and above all – to empty the contract of its substance and of any useful effect “, further considers this legal opinion, which also considers” problematic “the” compensation clauses according to which the Member States […] undertake to compensate the manufacturers […] for the (almost) total damage that vaccines could cause to third parties “because they would deprive manufacturers” of a real incentive to deliver and guarantee effective and safe vaccines, which amounts to voiding [leur] commitment of its substance. “
FAKE OFF
Contrary to what the initial tweet suggests, the contracts analyzed by this legal opinion are not confidential: they are available sure
the site of
the European Commission – although some parts of the documents remain hidden for confidentiality reasons.
The clauses of each advance purchase contract referred to in the legal notice, on the other hand, relate to the liability of the vaccine manufacturers concerned. The agreement with CureVac provides, for example, that the laboratory “cannot under any circumstances guarantee or assume any liability whatsoever. […] on the fact that the [vaccin] will be readily available or produce the desired effects. “
But this was established in the summer of 2020, when uncertainty still reigned around these products, as reminded to 20 minutes the European Commission: “These contracts were signed before the vaccines were authorized and available, while they were still under development. When they were signed, no laboratory could guarantee 100% that it would be able to develop an effective and safe vaccine that would be validated by the EMA. This is why contracts do not apply in cases where the laboratory fails to produce a vaccine that works, which fortunately has not been the case so far. “
“These contracts do not release the laboratories from their responsibility”
In addition, AstraZeneca, Sanofi and CureVac remain fully responsible in the eyes of the law in the event of a complaint leading to a conviction for possible serious adverse effects or the defect of the vaccine, as explained to us by Marie Albertini, industrial risk lawyer at the cabinet PDGB: “These contracts do not release the laboratories from their responsibility, but from the cost of this responsibility, which must be compensated by the Member States of the European Union. If a citizen files a complaint, it is the laboratory that will be in front of him in court and not the State. But if the laboratory is condemned, it is the State which will have to ensure the compensation. “
“In the event of a complaint, it is the laboratory that remains responsible”, replies the European Commission: “The logic is as follows: in the case of possible side effects which could not be anticipated at the time of the authorization of When EMA is placed on the market, damages can be paid by the Member States. “
“This was an extremely important condition for the laboratories: in the absence of this type of clause, some of them would not have wanted to commit to taking the financial risk of developing a vaccine in very short deadlines ”, concludes the European institution, which already indicated, in August 2020, at the time of the entry into force of the contract signed with AstraZeneca that in order to “compensate for the high risks taken by the manufacturers, the advance purchase contracts provide that the Member States compensate the manufacturer for the responsibilities incurred under certain conditions ”but that“ the responsibility remains with the companies ”.