Experimental drugs, in short, are those without
scientific evidence of efficacy and safety, and still in the research and
testing phase, but the Brazilian Supreme Court has reached a result regarding
the issue of high-cost drugs without ANVISA registration.
According to them, "supply and import will
never be justified" and "the State cannot be required to supply
experimental medicines. […] There is no chance that the judiciary can force the
state to provide them."
However, with regard to medicines with proven
efficacy and safety, but without registration in ANVISA, the Supreme Court
established the requirements for its provision by the State through a judicial
decision.
The first requirement is "administrative
default," consisting of ANVISA's unreasonable delay in considering the
application for registration of the drug, that is, that the deadlines set by
the law are not respected.
For STF the inertia of ANVISA in these specific
cases would be responsible for preventing patients from having access to
necessary medicines, unduly frustrating the enjoyment of their fundamental
right to health and thus justifying judicial intervention.
The only exception to this first requirement
will be the cases of drugs called "orphans", which are those marketed
for rare and ultra-rare diseases, which because of lack of economic viability
there is no request for registration by the pharmaceutical industry.
The second requirement is the absence of a
therapeutic substitute registered in ANVISA for the treatment of the patient's
disease. If the patient has another "satisfactory" option for the
treatment of the disease with due sanitary registration, the Judiciary can not
compel the Public Power to import the drug requested by the patient.
The third requirement is that the judicially
filed drug be registered in reputable regulatory agencies outside Brazil.
The fourth and final requirement is the
demonstration of the applicant's financial and social incapacity to pay for the
purchase of the drug. This scenario may be positive for solid technology
industries that have technological innovation as their basis.
SOURCE: https://tudorondonia.com/noticias/tema-500-do-stf-dever-do-estado-de-fornecer-medicamento-nao-registrado-pela-anvisa,31385.shtml