The Constitutional Court rejected the last appeal of women affected by the side effects of the drug Agreal, provided for two decades to alleviate certain symptoms of menopause.
The second chamber of the Guarantee Court, as learned by elDiario.es, rejected this Monday the request of the Agreal Luchadoras association to consider that the Spanish health authorities had incurred inactivity by not responding to their requests and complaints in recent years against laboratories. Sanofi.
The drug Agreal was marketed in Spain between 1983 and 2005 and was designed for postmenopausal women to combat the hot flashes it produces. Its active ingredient was veralipride and it was in 2004 that the first alerts were issued in the Spanish pharmacovigilance system: there were cases of disorders and withdrawal syndrome in women who had followed the treatment and one year later, the Spanish Medicines Agency revoked the marketing authorization. he. It was permanently withdrawn from pharmacies in September 2005.
The association’s calculations speak of several thousand women concerned who filed hundreds of legal complaints, the vast majority rejected, in particular because of statute of limitations: too much time had passed. The National Court, as it itself explains in some of its resolutions, has issued more than 90 judgments rejecting this type of claim and declared in this trial that “we were not faced with a massive poisoning, but that the withdrawal was instead based on a new assessment of the benefit-risk balance.
“The appearance of adverse effects does not in itself imply that it is a defective pharmaceutical specialty,” added the court before rejecting the responsibility of the Spanish health authorities for inactivity. The association of those affected notably requested that the Spanish Medicines Agency recognize the adverse effects, prepare a report on the subject and the creation of a multidisciplinary working group on the subject.
The case was also the subject of unsuccessful criminal proceedings. Five years ago, the National Court filed the complaint that the same association had filed against the French group Sanofi and several of its managers for injury crimes. The judges recognized that the marketing of the drug had been stopped at European level, but without it having been proven that its consumption generated massive adverse effects in patients.
The second chamber of the Constitutional Court, composed of six judges, decided to reject this appeal. Court sources explain to elDiario.es that, among other arguments, we cannot accuse the health authorities of inaction in the face of the complaints of those affected by Agreal: the administrative response existed, even if it was contrary to their resources and to their requests for repair. . because of the side effects of a drug which, they have denounced for years, is “poisoning” “women all over Spain”.
Depression, anxiety and withdrawal syndrome
Over the past two decades, people affected by this syndrome and the side effects of the drug have denounced the fact that the Sanofi group designed a pharmaceutical product “which harmed health, by inventing a pharmacological indication without scientific basis”, in failing to alert the public. hiding, as they said, for example in a complaint rejected in 2019, that there were trials that showed from the beginning the possibility of these “adverse reactions”. They accuse Sanofi and its subsidiaries of having launched a drug causing “neurological, psychiatric and rheumatological disorders”.
The judges rejected their requests through civil and criminal channels, going so far as to accuse the people concerned of having initiated all these legal procedures without providing a “scientific basis”, which the National Court defined as “an attempt to obtain a repair refused”. ” ” presenting “different medical studies that attempt to self-servingly deny” the conclusions of the Spanish Agency for Medicines and Health Products, “coinciding” according to the National Court with the European health authorities.
The criminal proceedings were buried and the people concerned, through the association, embarked on a new legal path aimed at having the courts declare the inactivity of the Ministry of Health “by not recognizing the Agreal syndrome and the damage caused by the drug and not allowing “so that doctors can know the etiology of the damage.” A request rejected in 2020 by the National Court and which has now also been definitively rejected by the Constitutional Court.
The associations denounced that the actions of the Spanish health authorities had violated their fundamental rights to “physical and moral integrity, freedom, equality, honor and effective judicial protection”. The public prosecutor, in its opposition to his latest complaint, explained that the National Court had issued “more than 90” decisions rejecting his appeals and complaints. In which those affected claim that Agreal ruined their lives.
