A French administrative appeal court has just overturned two decisions by the French Drug Agency on the grounds of illegality
The ANSM, the French Drug Agency, took two formal decisions in 2019 suspending the distribution of an alleged investigational medicinal product and what the Agency considered to be an illegal clinical trial, respectively. The Agency considered that an urgent context required that both be suspended immediately, without an adversarial procedure, as the law exceptionally allows. In practice, however, several months elapsed between the time the Agency became aware of the alleged illegal situation and the time it imposed sanctions.
In an important decision this month (March 2023), the Administrative Court of Bordeaux, before which the matter was brought, overturned the ANSM decisions and ruled that the Agency could not invoke the existence of an emergency context or prevent the targeted company from presenting its arguments to defend itself against the Agency's sanction.
In many respects, especially for pharmaceutical and medical device companies and their management (e.g. qualified persons), the Court's ruling is crucial: it shows that the Agency may not be acting in accordance with the law in its sanctions, and may also be misinterpreting the provisions of the French Public Health Code. This is all the more true as it is not the first time that the French administrative courts have overturned unfavorable and excessive decisions taken by the Agency.
In practice and in the near future, this means that healthcare companies must rigorously assess whether any potential unfavorable decision by the Agency concerning their company or their products is in line with the law and if not, companies should consider bringing the matter before the courts in order to have it overturned. It is true in France, but also in other European jurisdictions like Germany, Spain or the UK, where local courts have also already held similar judgments which have invalidated some national health authorities decisions.
In an important decision this month (March 2023), the Administrative Court of Bordeaux, before which the matter was brought, overturned the ANSM decisions and ruled that the Agency could not invoke the existence of an emergency context or prevent the targeted company from presenting its arguments to defend itself against the Agency's sanction.
In many respects, especially for pharmaceutical and medical device companies and their management (e.g. qualified persons), the Court's ruling is crucial: it shows that the Agency may not be acting in accordance with the law in its sanctions, and may also be misinterpreting the provisions of the French Public Health Code. This is all the more true as it is not the first time that the French administrative courts have overturned unfavorable and excessive decisions taken by the Agency.
In practice and in the near future, this means that healthcare companies must rigorously assess whether any potential unfavorable decision by the Agency concerning their company or their products is in line with the law and if not, companies should consider bringing the matter before the courts in order to have it overturned. It is true in France, but also in other European jurisdictions like Germany, Spain or the UK, where local courts have also already held similar judgments which have invalidated some national health authorities decisions.