The Italian government is circumventing the obstacle of the compulsory vaccine against Covid with recommendations and limitations on personal freedom. Giuseppe Liturri’s analysis Conditional
Marketing Authorization (CMA). This is the key to understanding why the Italian government has not gone down the road of formal introduction of the Covid vaccine obligation and has instead bypassed the obstacle with recommendations and limitations to personal freedom which in fact surreptitiously introduce the ‘obligation.
This specific authorization regime has a twofold consequence: if the authorization is not standard but conditional, the obligation would hardly stand up to the constant jurisprudence of the Constitutional Court which, with regard to the vaccine obligation provided for by law (also permitted by article 32) imposes on the legislator the constraint of rigorous technical-scientific investigations of a definitive nature and therefore not subject to conditional authorization, as for anti Covid vaccines.
Furthermore, this particular type of authorization is based on a consolidated framework of rules, dating back to 2006. It is the EU Regulation 507, which governs the CMA regime in detail. Of course: no “experiment” is underway with these vaccines, but a well-tested procedure is being followed. In summary, the authorization is issued even before the availability of all clinical and pharmaceutical data, on the basis of a first set of incomplete data that allow it to be stated that the “benefits for public health deriving from the immediate availability on the market of the drug in question outweigh the risk inherent in the fact that additional data is still needed ”. The examination of such data, even if provisional and incomplete, is carried out rigorously, meticulous and independent – according to the EU Commission that grants the authorization – and led to the authorization of the Pfizer vaccine on December 21, 2020, followed by Moderna on January 6, AstraZeneca and, lastly, Johnson & Johnson on March 11. This authorization has a duration of one year and can be renewed.
Meanwhile, the EMA (European Medicines Agency) continues to receive clinical data even after marketing and the pharmaceutical companies commit to a well-defined plan of activity, in particular the completion of clinical trials. This process allows a considerable reduction of the normal evaluation times because the EMA has the data as they become available, receiving them even before the application for authorization, without waiting for the release at the end of all the evaluation phases. In short, a regulatory context that was conceived for “medicines to be used in emergency situations in response to threats to public health” and which was promptly applied for the emergency of the pandemic.
However, the “vulnus” compared to the ordinary procedure is evident, consisting of the risk of acquiring clinical data subsequent to authorization that overturn the benefit / risk ratio that led to the initial authorization.
The problem is that we understand that this information has not been brought to the attention of citizens with the necessary relevance, as instead recital 10 of the regulation states: “It is advisable to provide patients and healthcare professionals with clear information on the conditional nature of authorizations. This information should therefore be clearly stated in the summary of product characteristics and in the
package leaflet of the medicinal product in question “. We have verified that for all vaccines, both in the summary and in the package leaflet, it is indeed stated that they are “medicine subject to additional monitoring” and, shortly thereafter, that “this medicine has been authorized under a” conditional “procedure. This means that further data on this medicinal product must be provided.
The European Medicines Agency will review new information on this medicine at least annually and the SmPC will be updated as necessary. ”
But this is information that is not disclosed to the patient when he signs the informed consent form, when he declares that “I have read, it was illustrated to me in a known language and I fully understand the information note drawn up by the Agency Italiana de Farmaco (AIFA) “. In fact, this information note does not at all contain the above warning for any authorized vaccine. Basically, when the citizen signs the consent, nothing is said to him about the particular vaccine authorization regime, in defiance of the regulation which instead deems it at least “appropriate” to provide that information. They are asked to read the package leaflet (which instead contains them) and we challenge anyone to claim that they have read even only the 2/3 pages of the AIFA information note attached to the consent form,
Then one wonders how it is possible – in a vaccination campaign of such a vast scope that affects millions of Italians – to have omitted information of such importance that it is instead considered appropriate and necessary precisely by the EU regulation that governs conditional authorization. The deficiency is even more serious if we reflect on the fact that the enormous media pressure and the recent decrees on the green certificate have made the vaccine mandatory, of which, even more so, the citizen cannot fail to know all the characteristics.
It could therefore open the side for what jurists call consent marred by error or, worse, malice. Basically, the formation of the will of the vaccinated subject was vitiated at least by an error, because at the basis of his decision there was a false or distorted representation of reality and therefore that consent can be canceled. Too bad it has already produced irreversible effects.
We do not know what value this hypothesis may have, we know instead that, for the umpteenth time, the citizen has been treated like a child to whom it is better not to tell the whole truth, to avoid having a tantrum.
(Integrated and updated version of an article published in the newspaper La Verita)
