Great powers come with great responsibilities. Great constraints too. While some health professionals, essential in the management of the health crisis, are excluded from the hospital for not having submitted to the vaccination obligation, a more discreet battle is being played at this very moment with the Agency. National Medicines and Health Products Safety Authority (ANSM) and the European Medicines Agency (EMA).
These authorities were recently approached by the lawyer of three associations to ensure compliance with European regulations and European authorizations (conditional marketing authorizations) from which anticovid vaccines benefit.
A simple courtesy visit that turns out to be a cobblestone in the pond since neither the French agency nor the European agency can answer. Me Teissedre has indeed just received this surprising response from the management of the European Medicines Agency: “We are currently examining your request and will answer you in due course”.
Curious answer when we know that for several weeks the time not only has come, but it has also passed! Indeed, regulatory deadlines have expired. This is the case for the time limit to be observed for the annual renewal of each authorization issued to each of the vaccines currently on the market, but also the time limits available to manufacturers to transmit to the AEM the additional data relating to the characteristics of the vaccine products.
We are not talking about nothing since it is a question of knowing in particular the composition of the active substance of vaccines and excipients! Why then does the European agency maintain the mystery when a lawyer asks him such legitimate questions, knowing that the French agency has already kicked in touch by referring the cumbersome request to the European Medicines Agency?
See also: Data relating to vaccines: the ANSM does not have the information requested by Me Teissedre
Manufacturers obviously have an armada of competent lawyers who know these deadlines by heart. So imagine that the schedule for vaccine evaluation would not be respected is it really reasonable?
The answer is yes. And this is even the preferred hypothesis. The Prescrire magazine devoted in November 2017 an article on the occasion of the 10 years (2006-2016) of the practice of conditional marketing authorizations. These authorizations are advance authorizations responding to an emergency. Under each of these authorizations, the manufacturers undertake to provide the European agency regularly, post-authorization, with essential data on the product placed on the market.
Except that the journal Prescrire noted in its article of November 2017 that manufacturers rarely play the game once the authorization has been granted; the agency then tends to be very lax. The problem here is that the whole world is being vaccinated, under duress, that the vaccination of European children is being considered and we are talking about the 3rd, 4th dose outside of any framework even though many States have 2 out of 4 vaccines (Janssen and AstraZeneca) withdrawn from the market.
It is therefore more than difficult in such a context to go under the radar … Another explanation is also given by the MEP Michèle Rivasi, who declares in a recent video that manufacturers need to protect their know-how, which would explain their refusal to deliver strategic information.
Madame Rivasi was able to ask the European Medicines Agency the question: “Do you know all the ingredients that have been put into a vaccine? They told me that no, whereas normally even if there is a confidential part, she should have access to this data ”.
The deputy @MicheleRivasi in response to a question from @BanounHelene : the European Medicines Agency does not know all the ingredients of vaccines!
Full video: https://t.co/GQL15egQHT pic.twitter.com/EzWTl4TSt1
– Mouâd Boutaour Kandil (@boutaour) September 24, 2021
This also means in passing that the European Commission is contractually committed to guaranteeing manufacturers against all the financial consequences linked to vaccine disappointments, including lawyers’ fees, without having been able to assess the risk beforehand.
Note that while they advocate freedom-killing and binding laws, the health authorities are not even able to enforce the obligations who are theirs. In law, the vaccination obligation, enshrined in article 12 of the law of August 5, 2021, on the validity of which the Constitutional Council has not yet ruled, is therefore more fragile than it appears.
Obviously the legislator is not so sure of himself in enacting it since the law which institutes it also provides that a decree, taken after the opinion of the High Authority of Health, can suspend the obligation depending in particular on medical knowledge. and scientists. However, insofar as this knowledge is impossible, it can be considered that the law can no longer be applied and the obligation can no longer be maintained. The vaccination obligation, in the state of knowledge, is contrary to free and informed consent, and also exposes the public authorities to a considerable risk because the responsibility for the State is not the same depending on whether vaccination is compulsory. or not.