Judge dictates that the social work must cover “without punctures” device to patient with diabetes

A Federal Court in Paraná ordered a mutual to cover a novel non -invasive method and "without punctures" for glucose level control.

An unprecedented ruling by the Federal Court of First Instance of Paraná N ° 2, by Dr. Daniel Edgardo Alonso, met days ago and is great news for people suffering from diabetes and who seek to avoid punctures.It would be an unpublished sentence in Argentine territory, with respect to the coverage of said technology in a patient with diabetes.

A young Paranaense, presented an amparo in justice against the organization of direct business services (OSDE) of Paraná, in which he requests “the permanent and free integral coverage for the treatment of the diagnosed pathology diagnosed type 1 diabetes, of free freestyle kitinitially (1 reader + 2 sensors), as prescribed and justified by doctors, ”according to the document.

the device

The National Administration of Medicines, Food and Medical Technology (ANMAT) approved in August 2017 the "Free Freestyle, the Glucose Monitoring Flash System".It is an alternative to the traditional "punctures" glucometer for people suffering from diabetes.It allows them to track their glucose levels in an non -invasive way with an smart watch.
The meter consists of a discreet sensor to place adhered to the skin that measures automatically and continuously stores glucose, day and night readings, and a sensor that scan the levels and allows you to see the data collected by the sensor.

The mechanism allows to be alerted by a warning of alarming changes in glucose levels, avoiding falling into dangerous states of hypoglycemia or hyperglycemia.

the patient's request

The desire to be a mother is central in the patient's request.Nadia argues that "chronic diabetes suffering from nine years of age and emphasizes that the ailment does not disappear, so it will require life treatment."

And the amparo presented by the young Paranaense indicates that “a pregnant diabetic woman needs an even more exhaustive treatment of her illness, which translates into greater daily measurements and a thorough control of the administration of insulin and stresses that the project ofBeing a mother, motivates the need to improve your quality of life, having the disease under control. ”

In addition, the patient with diabetes states "that free freestyle is able to monitor blood glucose levels through scanning, without punctures" and argues that "motivates the request of this new technology, her personal desire to be a mother", alleges in his appeal filed before the Federal Court of First Instance of Paraná N ° 2.

the response of the mutual

The Organization of Direct Entrepreneurs (OSDE) services "rejected the patient's request for inadmissible" and states that it had guaranteed the coverage provided for in the adhered plan.In addition, "he adds that the required device is not provided in the OSDE regulations."

On the other hand, the mutual alleges that “it has rigorously covered and provided reactive, disposable, insulin and in 2016of supposedly violated law, because the social work acted within the legal norms. ”

Osde also argued before the patient's requirement that "the requested treatment is not within the Compulsory Medical Program (PMO), nor in the Diabetes Law and that has not incurred any omission in relation to its affiliate."

Also, theMutual said that "ANMAT has warned, in relation to what is requested by the plaintiff, limitations, risks and side effects, which could even put the possibility of pregnancy desired by the shareholder."

the foundations of the judge

According to Federal Judge No. 2 of Paraná, by accepting the amparo filed by the patient with diabetes that “Diabetes Law provides that the standards for provision of medicines and supplies must be reviewed and updated at least every 2 (two) years,In order to include in coverage the pharmacological and technological advances, which are applied in diabetes therapy and promote an improvement in the quality of life of diabetic patients.

The coverage of medications and diagnostic reagents for self -control of patients with diabetes will be 100% (one hundred percent) and in the necessary amounts according to medical prescription.To access the provisions of the previous paragraph, accreditation will only be necessary, by means of a medical certification of a public health institution, of the status of a diabetic patient, ”said the head of the Court.

In this regard, the judge points out that "arises from the documentary evidence that is accredited in cars, the need for the amparista of having the reference device, in attention to the time of the disease, and for presenting an important glycemic variability,"Dr. Alonso summarizes.

According to the ruling, the judge explains that the mutual "argues that the new technology, whose coverage intends the plaintiff, is not contemplated in the Compulsory Medical Program (PMO), and consequently, would not be obliged to cover it."When referring to the aforementioned argument, the judge highlights that “it must be remembered that the PMsitting in international treaties and the National Constitution, ”says the magistrate.

“For this reason, such circumstance cannot, in any way to constitute a barrier for the effective protection of conculsed rights.The defendant should not excuse himself in the non -mandatory one he refers, since the benefits established in the PMO constitute an unavoidable basic floor, which is subject to periodic update attentive to the dynamic character of the evolution of medical science, ”The judge stands out and cites a resolution of the Federal Chamber of Appeals of Paraná that adopted this criterion in another case.

Right to Health

The head of the Federal Court of First Instance of Paraná N ° 2, by Dr. Daniel Edgardo Alonso and whose secretary is Andrea Todoni, explains in its resolution that “the doctor treating the amparista explained how would improve her quality of life with the use with the useFree Freestyle, so in such a context, arriving at a solution contrary to the claim of the shareholder would bring a Franco excess of her health, especially as it is a condition that affects her since she was a child, which will accompany her for the rest of the rest of theHis life, and that requires special controls for his plans to be a mother, ”he argued in the ruling.

In addition, the judge argues that “the conduct adopted by the actuated (the Mutual OSDE) is harmful to the right to health of the plaintiff, since before the express indication of the use of a new technology to improve the quality of life of the affiliate, he remained in his position to deny the coverage. ”

the conclusion of the ruling

“Taking into account this aspect and the aforementioned normative plexus, the defendant, is forced to provide the coverage request by the shareholder.Therefore, and in order to preserve the physical integrity of the patient and procure himA better quality of life, it is appropriate to admit the action of amparo attempted, ”says the resolution.

For all the above, the judge resolved “to make room for the action of amparo filed and order the action organization of direct entrepreneurs (OSDE) Paraná filial that immediately grants the comprehensive, permanent and free coverage of free freeyle free(1 reader plus 2 sensors), as prescribed by treating doctors, for the plaintiff ”.