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The long-awaited coronavirus vaccines will be available in the European Union in a few weeks. The European Commission has negotiated contracts with laboratories on behalf of all Member States. In total, six pre-purchase contracts have been concluded with the laboratories so far. Others may follow in the future depending on the progress of other vaccine candidates. However, these are confidential contracts that no one has seen, much to the chagrin of NGOs and some European elected officials.
They are actually commercial contracts on new and innovative technologies. Companies don’t want their competitors to retrieve sensitive industrial information. As the vaccine race is a global competition, European negotiators also want to keep quiet about their tactics.
Brussels aware of the suspicions
The risk is that this will feed suspicion. Brussels knows this well. The Commissioner for Health plans to make the contracts accessible under certain conditions to elected European officials once all negotiations have been concluded.
On the other hand, there is total transparency on the other points. This transparency applies to data from all clinical trials. Laboratories must send them to the European Medicines Agency (EMA), which reviews this information. After marketing authorization (MA), they will be accessible to the public and scientists around the world on the agency’s website. This explains why the European Union has not concluded contracts for Chinese or Russian vaccines: the laboratories do not want to communicate their data.
Who will be responsible?
On Wednesday on Europa 1, geneticist Axel Kahn said the labs will not be responsible for any side effects. In fact, there are two scenarios. The first and most common case is the known side effects, which are revealed during clinical trials. In the European legislation, included in our civil code, the laboratory is responsible, if it has been negligent or has concealed things. On this, the negotiators did not give up.
“ We asked the laboratories for a speed company “
In the second, much rarer case, of a disease that broke out years later and that in good faith no one could have foreseen, the industrialists have obtained that the states take on the compensation. “We asked them for a feat of speed,” explains Medicine Professor and Macronist MP Véronique Trillet-Lenoir. Of course, the risk-taking by manufacturers is important, as are the benefits they will derive from a vaccine, but I find this sharing of legal responsibilities to be balanced. It is important to remember that vaccine evaluation is very rigorous. We will only market products that are as safe as possible. “
If one day there is an unexpected problem with a French patient, will the state pay? “Yes, but it won’t be the first time”, blurs the macronist MEP. “For example, the H1N1 flu vaccine would have caused some rare cases of sleeping sickness. Patients were able to file a file with the medical injury compensation office. It is therefore a possibility already foreseen in the health code. public “. For experts, this is one of the risks that cannot be predicted, just like natural disasters.
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