Smeralda, Celeste, Daniele, Gioele and Sofia, Federico will no longer need a judge to be able to receive relief from devastating diseases. Stem cell treatment for them and for those who have already started a therapeutic protocol will continue. The decision comes as a surprise from the Council of Ministers. "Exceptionally, the continuation of treatments that do not comply with current legislation is granted for patients for whom they have already been started at the date of entry into force of the decree, always with clinical monitoring," we read in a note.
As far as stem cells are concerned, "there is provision for more extensive, fully-fledged legislation regulating advanced therapy medicinal products prepared on a non-repetitive basis, with clinical monitoring". In short, in a few "bureaucratic" lines, the Monti government gives the parents of children, who fight for the right of their daughter to feel better, a respite from anxiety and stamped papers.
The note of the Council of Ministers. The Council of Ministers has therefore approved, on the proposal of the Minister of Health, Renato Balduzzi, the decree law, invoked by many, which contains "urgent action" in health matters. Only a couple of days ago a judge from Livorno granted the continuation of treatment for Sofia, 3 years and a half, suffering from a serious neurodegenerative disease that has already taken away her sight. She will be able to complete the treatment at the Brescia Hospital with stem cells produced using the Stamina method. The magistrate had accepted the appeal, ex art.700, presented by the parents of the child, helped in the fight in the recognition of this right guaranteed by the Constitution, by the drafting of the transmission "Le Iene".
Sofia and the other sick children. The struggle of families. The story of Sofia is similar to other cases of children suffering from rare diseases or for whom science has not yet found a therapy. The stem cell treatment developed by the Stamina Foundation, and considered by some to be one of the few that can produce appreciable improvements, was blocked by the Ministry of Health and Aifa because it still lacks scientific evidence and therefore considered dangerous. Until now, it had been the judges who had expressed their opinion on the possibility for families to submit their loved ones to compassionate care (as in the case of Celeste another child).
The judge of Florence, last November, had allowed a first infusion of stem cells and Sofia had begun to feel better, managing to react even in the light, despite the sight was now lost.
Then, however, finally the court decided to deny the treatment and the second infusion had not been and the condition of the child had suffered a progressive deterioration. After the interest of the Minister of Health Renato Balduzzi, in recent days, the situation had apparently been unblocked and Sofia on March 14 had been subjected to a new infusion. But the hospital had rushed to point out that, in the absence of an official measure of the ministry or a court ruling, that would be the only infusion for the little patient with metachromatic leukodystrophy. The family's lawyer, Giuseppe Conte, had once again played the court's card to guarantee her the right to continuity of treatment. And the judge of Livorno had accepted the appeal. Sofia's mother had also explained that after the infusion the little girl was better: "She wakes up without fever in the morning and has no signs of suffering on her face.
In recent times, the number of families who turned to the judges to obtain the green light for treatment had grown a lot. After Smeralda, Celeste, Daniele, Gioele and Sofia, Federico, a 26-month-old child from Fano suffering from Krabbe's disease, had also arrived. In his case, the court of Pesaro had accepted the complaint submitted by the parents who asked for the son to be subjected to stem infusion according to the method Stamina always in the Lombard hospital.
Now all these children will not need a judge to be "treated". "The Republic protects health as a fundamental right of the individual and in the interest of the community, and guarantees free treatment for the needy. No one can be obliged to undergo a specific medical treatment except by law. The law cannot under any circumstances violate the limits imposed by respect for the human person," says Article 32 of the Constitution.
Minister Balduzzi: "Care taken cannot be interrupted". The rule "is based on the ethical principle that a treatment already underway that has not given rise to serious side effects must not be interrupted", explains the Minister of Health, Renato Balduzzi. The decree, stresses the Ministry of Health, states that "all patients who have begun treatment with stem cells prepared with the Stamina method will be able to complete their protocols even if the laboratory of reference (in this case that of the Civil Hospital of Brescia) is not authorized.
The decree, notes Balduzzi, "also clarifies that the treatments for which preparatory acts have been carried out (the collection of cells from the patient or donor for therapeutic use) and those already ordered by the judicial authorities must also be considered as 'initiated'. For all these therapeutic treatments there will be a careful evaluation of the results, with the acquisition of all the clinical data of the patients undergoing treatment.
The decree also provides that from now on all so-called "advanced therapy drugs prepared on a non-repetitive basis", which include stem cell treatments, may only be used in a public hospital, university clinic or institute of hospitalization and treatment of a scientific nature. With a ministerial regulation to be issued in the coming days, announces the ministry, will also be established "more precise rules to ensure patient safety and will be established a precise procedure for assessing the results of the use of these therapies.